Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery
Incomplete recovery from any surgery
The subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer < 30 days from W1D1 (surgery)
No prior chemotherapy or surgery for rectal cancer
The patient has elective or planned major surgery to be performed during the course of the clinical trial
Patients must begin treatment as outlined in the protocol within 36 days of definitive surgery (day of surgery is day 0; definitive surgery includes second surgeries to resect residual tumor)
Suitable for breast conserving surgery and radiotherapy
Diagnosis confirmed on core needle, vacuum-assisted or surgery ? 90 days of registration
Patients must be adequately recovered from surgery at the time of randomization
The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration
No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
Radiotherapy may be given before or after protocol treatment per standard of care guidelines; when radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation\r\n* Post-mastectomy radiotherapy is required for all patients with the following:\r\n** Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of lymph nodes at the time of definitive surgery\r\n** For patients with primary tumors < 5 cm or without lymph node involvement prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician\r\n** Radiation of regional nodal basins is at the discretion of the treating radiation oncologist\r\n* NOTE: Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy
The patient must have recovered from surgery with the incision completely healed and no signs of infection
Patients with microscopic positive margins after definitive surgery
Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
Patients must not have any unresolved wounds from previous surgery
Patient has undergone total resection of the primary tumor with curative intent\r\n* NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days
Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
Patients with codeleted low grade gliomas must also be considered “high risk” by exhibiting one or more of the following characteristics:\r\n* Age >= 40 and any surgical therapy\r\n* Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)\r\n* Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)\r\n* Intractable seizures
Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery
No major surgery =< 7 days prior to registration and no minor surgery =< 3 days prior to registration (with the exception of intravenous access placement, e.g. Hickman or peripherally inserted central catheter [PICC])
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422\r\n* Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)\r\n** Note: patients must begin treatment within 36 days of definitive surgery
Patients with residual macroscopic disease after surgery
Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:\r\n* Positive pelvic nodes\r\n* Positive parametrium\r\n* Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)
The primary tumor site must be controlled prior to registration\r\n* For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration\r\n* The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference\r\nFor those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration\r\n* The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy within 28 days prior to step 1 registration; patients must undergo the diagnostic laparoscopy to rule out peritoneal disease spread
Patient must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing; patients who received radiation therapy (RT) must be registered to step 3 within 28 days after discontinuing RT; patients who did not receive RT must be registered to step 3 within 56 days after surgery
Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
Must have adequate recovery from prior surgery (e.g., healed scar, resumption of diet, etc.)
Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
One of the breast disease stages listed below:\r\n* Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins\r\n* Neoadjuvant chemotherapy was not administered\r\n** If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T1-3, N1-2a following definitive surgery\r\n* Neoadjuvant chemotherapy was administered\r\n** If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N0, pathologic staging must be T1-3, N1-2a following definitive surgery\r\n** If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N1, pathologic staging must be T0-3, N0-2a following definitive surgery\r\n** If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the criteria listed below), pathologic staging must be T0-3, N0-2a following definitive surgery\r\n*** Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells)\r\n*** Positive core needle biopsy (ie, demonstrating invasive adenocarcinoma)\r\n*** Positive sentinel lymph node biopsy (ie, demonstrating invasive adenocarcinoma)
Recovery from surgery with the incision completely healed and no signs of infection
Microscopic positive margins after definitive surgery\r\n* Note: Patients with microscopically focally positive margins following lumpectomy or mastectomy are not excluded if re-excision is not technically feasible and/or there is no benefit to further surgery based on the extent and location of the positive margin
History of ipsilateral or contralateral axillary surgery for any condition
Patient has had surgery within 4 weeks prior to first dose
Eligible for surgery with curative intent
Subject has received surgery within the last four weeks.
Surgically unresectable site as determined by tumor board or surgeon or patients who decline surgery
Patients who cannot undergo surgery
Autologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgery
All patients who have surgery performed must have a cranial MRI pre-operative and post-operative (should be done within 72 hours of surgery or within 21 days following surgery)
Patient must have recovered from the surgery
Recovery from the effects of prior GBM surgery as defined by the Investigator;
Elective or planned major surgery to be performed during the course of the trial
Major surgery requiring general anesthesia within 14 days before the first dose of any study drug or a scheduled surgery during study period; (placement of a central line or port-a-catheter is acceptable within this time frame and does not exclude the patient)
Participants must meet the following windows from procedures (there is no window required for port placement since there is no anticipated impact on wound healing with bavituximab):\r\n* Major surgery (ex. craniotomy) within 3 weeks of initiation of treatment\r\n* Brain biopsy within 2 weeks
Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery [Period 1]
Open surgery in ipsilateral breast within 1 year.
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Patients must have fully recovered from all effects of surgery; patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy; minor procedures requiring “twilight” sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Patients must have fully recovered from all effects of surgery; patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy; minor procedures requiring “twilight” sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator
COHORT B: Progressive brain metastases after prior local CNS-directed therapy such as radiation or surgery as defined by:\r\n* Untreated measurable lesions in patients that have received surgery and/or SRS to one or more other lesions\r\n* Residual or progressive lesions after surgery if asymptomatic\r\n* Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed are eligible; lesions treated with SRS may be eligible if there is unequivocal evidence of progression
Surgery to the lesion in question is allowed if size criteria outlined above are met
Patients with elective or planned major surgery to be performed during the course of the clinical trial
Patient has had surgery within seven days prior to the date of informed consent.
Patients for whom surgery would be deemed appropriate rather than radiotherapy
After undergoing surgery, patients may be optimally or sub optimally debulked
Participants who underwent major surgery (including craniotomy) or significant traumatic injury within 28 days prior to initiating therapy; baseline MRIs for participants who underwent salvage surgery must be obtained within 14 days of registration (similar to other patients who do not have surgery) and there must be measurable disease
Successful Avatar engraftment from initial surgery or surgery/biopsy of recurrent cancer with successful expansion and treatment outcome of Avatar therapy
Major surgery within 12 weeks before the first dose of cabozantinib; complete wound healing from major surgery must have occurred 1 month before the first dose of cabozantinib; minor surgery (including uncomplicated tooth extractions) is allowed if it occurred 28 days before the first dose of cabozantinib with complete wound healing at least 10 days before the first dose of cabozantinib; subjects with clinically relevant ongoing complications from prior surgery are not eligible
Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia
Subjects may not have a history of rectal surgery or lower gastrointestinal bleed
Patients with locally advanced BCC of the head and neck, consisting of at least one histologically or cytologically confirmed lesion >= 20 mm in longest diameter that is considered to be inoperable or to have a medical contraindication to surgery, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon; locally advanced disease is considered to include involved lymph nodes of the neck; a patient with regionally involved lymph nodes in the neck is considered eligible; the patient should be considered a candidate for radiotherapy and should not have medical contraindications to receipt of radiation therapy\r\n* If a patient has distant metastatic spread of BCC (e.g., spread to distant areas outside the regional lymph nodes, clearly non contiguous areas of bone involvement, or distant metastasis to lung, brain, or other visceral organs), the patient should be considered as having distant metastasis and is not eligible\r\n* Note: all lesions that the investigator proposes to follow as target lesions during the course of the study must have previously been histologically confirmed as BCC\r\n* Acceptable contraindications to surgery include: \r\n** BCC that has recurred in the same location after two or more surgical procedures and successful curative resection is deemed unlikely \r\n** Complete surgical resection is not possible or is deemed excessively morbid (e.g. invasion into cranial nerves or skull base, proximity to brain, spinal canal, or orbit) \r\n** Anticipated substantial morbidity and/or major deformity from surgery (e.g. removal of a major facial structure, such as nose, ear, eyelid, eye, or jaw; or requirement for upper limb amputation) \r\n** Medical contraindication to surgery \r\n** Patient refusal of surgery due to anticipated morbidity \r\n** Other conditions considered to be contraindicating must be discussed with data coordinator before enrolling the patient
Patients must have surgery planned to remove the desmoid tumor and either:
the desmoid tumor has already recurred after a prior surgery or
Be able to undergo protocol therapy, including necessary surgery.
Major surgery within 4 weeks of the first dose of BVD-523; tumor embolization procedure or ablation procedure within 2 weeks of first dose of BVD-523
The subject is a candidate for surgery or loco-regional treatment with curative intent.
Surgical and pathology reports that document surgery was limited to biopsy and histologic confirmation.
Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
Planned procedure or surgery during the study
Must be a candidate for salvage surgery
Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment
Subjects with active HSV-1 infection on current valacyclovir, acyclovir or ganciclovir therapy must be off treatment with any of these agents at least 7 days prior to surgery
Concurrent therapy with drugs active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir); participants must be off treatment with these agents for at least 7 days prior to surgery
The patient has elective or planned major surgery to be performed during the course of the clinical trial
Surgery within 4 weeks prior to study registration except for minor procedures. NOTE: Hepatic biliary stent placement is allowed. NOTE: Subject must have adequately recovered from the toxicity and/or complications of major surgery prior to study registration, as determined by the treating physician.
Completed pre-operative chemo radiotherapy followed by surgery
Did not receive concurrent chemoradiotherapy prior to surgery
Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
Surgical patients must have tumor that needs to be removed/debulked and is accessible for the neurosurgeon; need for surgery must be such that the patient can take drug for at least 10 days to maximum 14 days before surgery
Patients who are not candidates for major abdominal surgery due to known medical comorbidities
Major surgery (eg, requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (ie, unhealed wound); Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate
Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
Patients must have undergone radiation therapy and surgery as part of their standard of care\r\n* Stratum A: Radiation therapy must have started within 4 weeks of diagnosis by imaging or surgery, whichever is later\r\n* Stratum B: For subjects undergoing surgery for more extensive resection, radiation therapy should be started within 4-6 weeks from surgery\r\n* H3.3K27 mutation must have been confirmed in the tumor tissue in a CLIA approved laboratory
Major thoracic or abdominal surgery from which the patient has not sufficiently recovered yet
Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
Presence of any of the following risk factors after surgery:\r\n* Any positive surgical margin.\r\n* Adenopathy below the clavicles
Patients must have at least 14 days to recover from all prior treatment, including surgery, chemotherapy, immunotherapies, prior to enrollment on this protocol
No previous regional treatment (includes surgery, radiation or liver-directed arterial or ablative therapy)
Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer
Positive margins after definitive surgery
Nodal recurrences can be treated on this protocol but prior curative surgery for lung cancer must have been at least 6 months prior to the nodal recurrence
Patients who are less than 4 weeks from surgery (except biopsies) or have insufficient recovery from surgical-related trauma or wound healing
Not eligible for surgery
In the case of recurrent radiographically gross disease, pathologic diagnosis may be from time of original biopsy and/or surgery; pathology should be reviewed and confirmed at the participating institution
Patient must have had previous treatment with definitive surgery or radiation therapy or cryoablation
Must have completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitive-intent local therapy
Subject who used corticosteroids (excluding inhalers, eye-drops, and dermatologic corticosteroids) within 6 weeks prior to surgery;
Subject who has undergone platelet receptor GP IIb/IIIa antagonist therapy less than 48 hours prior to surgery.
At least 4 weeks post-surgery prior to first dosing of study agent
Possibility of a curative local treatment (surgery and/or radiotherapy)
Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 8 weeks to the date of surgery
Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients; a minimum of 4 weeks should elapse between any surgery and treatment on study; however, high-risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion
At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
Patients with a recent surgery should have recovered from all effects of the surgery and be cleared by their surgeon
No previous surgery for melanoma (other than complete macroscopic resection as stated above)(i.e. Not recurrent disease)
Timing of radiation must be according to the IRS protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery; the clinical characteristics dictate the need for or/and timing of surgery and radiotherapy in relation to the chemotherapy
Subjects must be co-enrolled on protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).
PRIOR THERAPY OR SURGERY
Patients must have recovered from the effects of surgery per treating physician’s judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment
Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
History of major surgery within 3 weeks or minor surgery within 1 week of roflumilast administration; major surgery includes, for example, any open or laparoscopic entry into a body cavity, or operative repair of fracture; minor surgery includes, for example, open surgical biopsy of palpable/superficial lymph node, or placement of vascular access device
Platelets > 80,000 compatible for surgery
Elective indication for nephron sparing surgery
The metastases have been treated by surgery and/or radiotherapy.
Recovery of reversible effects of prior surgery (i.e., incisional pain, wound drainage) to grade >= 1, and at least 4 weeks from prior surgery to treatment start
Scheduled to undergo chest surgery using either minimally invasive (VATS or robotic-assisted surgery) or open techniques (posterolateral, lateral, or anterior thoracotomy or requiring insertion of an inter-rib spreader/retractor) for a primary thoracic non-infectious indication under general anesthesia.
Major surgery within 28 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted)
The patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months.
Surgery unable to be performed between 1 – 3 days after radiosurgery
Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization.
Substantial recovery from surgery resection
Must have recovered from effects of surgery, postoperative infection and other complications of surgery
Prior oncologic (radical) surgery to the primary site
Pathologically confirmed NSCLC, not previously treated, with a plan to undergo surgery
Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Scheduled surgery: open elective CRS-HIPEC.
Pathologically confirmed SCCHN, not previously treated, with a plan to undergo surgery
History of ipsilateral cosmetic or reconstructive breast surgery
Has newly diagnosed disease (no prior chemotherapy, radiation or surgery with curative intent for this sarcoma diagnosis – prior surgery for diagnostic purposes are allowable)
If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
Additional site(s) of active disease (such as parenchymal liver and lung metastases, or supraclavicular nodal metastases), should be considered for treatment (off study) with radiation, surgery, or another form of local therapy, at the discretion of the study principal investigator (PI)
Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
Had hospitalization for infection or major surgery (e.g., requiring general anesthesia) within 2 weeks before enrollment or have not fully recovered from surgery; Note: subjects with surgical procedures conducted under local anesthesia may participate
Patients will be evaluated by the anesthesia team prior to surgery.
Prior intra-abdominal surgery within 4 weeks of trial enrollment.
Deemed ineligible for surgery by the enrolling physician
Major surgery within 2 months before enrollment; complete healing from major surgery must have occurred 1 month before enrollment; complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment; subjects with clinically relevant complications from prior surgery are not eligible
Participants may have had any extent of prior surgery and/or chemotherapy
Patients must have consented to surgery with an MSK gynecology (Gyn) surgeon
INCLUSION CRITERIA:\n\n        SONICS STUDY COMPLETERS:\n\n        Completed the final SONICS visit (M12) and have demonstrated maintenance of clinical\n        response on a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to\n        study entry.\n\n        ALL OTHERS:\n\n          -  Confirmed newly diagnosed, persistent or recurrent endogenous Cushing's syndrome of\n             any etiology, except secondary to malignancy (including pituitary or adrenal\n             carcinoma).\n\n          -  Elevated mean 24-hour UFC levels at least 1.5X upper limit of the normative range of\n             the study's central laboratory assay and from a minimum of three measurements from\n             adequately collected urine.\n\n          -  Presence of abnormal values from at least one of these two diagnostic tests:\n\n               -  Abnormal Dexamethasone Suppression Test (DST) OR\n\n               -  Elevated late night salivary cortisol concentrations (at least two measurements)\n                  each greater than the upper limit of the study's central laboratory normative\n                  range\n\n          -  Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed\n             until after study completion and agree to complete this study prior to surgery.\n\n          -  If post-surgical for CS-specific surgery, then no significant post-operative sequelae\n             remain and the risk of such sequelae is considered negligible.\n\n        EXCLUSION CRITERIA:\n\n        Subjects will be excluded from the study if ANY of the following criteria are met (NOTE:\n        exclusion criteria apply to and must be assessed in both cohorts):\n\n          -  Enrolled in SONICS but have not completed SONICS through Visit M12.\n\n          -  Pseudo-Cushing's syndrome based on assessment of the Investigator.\n\n          -  Cyclic Cushing's syndrome with multi-week periods of apparent spontaneous CS\n             remission.\n\n          -  Non-endogenous source of hypercortisolism, including pharmacological corticosteroids\n             or ACTH.\n\n          -  Radiotherapy of any modality directed against the source of hypercortisolism within\n             the last 5 years.\n\n          -  Treatment with mitotane within 6 months of enrollment.\n\n          -  History of malignancy, including adrenal or pituitary carcinomas (other than low-risk,\n             well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely\n             to require further treatment in the opinion of the treating physician, or squamous\n             cell or basal cell carcinoma of the skin).\n\n          -  Clinical or radiological signs of compression of the optic chiasm.
Deemed eligible for additional partial resection by treating physician and determined to be safe to receive 3 months of neoadjuvant therapy before planned surgery
Previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery, and
Subjects who are less than 21 days from surgery or have insufficient recovery from surgical-related trauma or wound healing.
Prior biliary bypass surgery
Any major surgery within 4 weeks, minor surgery within 2 weeks or other minor procedures requiring light sedation, such as endoscopies or mediport placement, within 48 hours prior to initiation of study treatment
Pituitary surgery within six months
Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment
Patients with anticipated contraindications to interval tumor reductive surgery
Laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
Dispositioned to single modality photon radiotherapy (i.e. no chemotherapy or previous therapeutic intent surgery).
Is ineligible for an operation based on medical or oncologic contraindications to surgery
Operable DCIS, suitable for breast conserving surgery
Participants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred > 28 days prior to enrollment
Patients must have fully recovered from all effects of surgery; patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy; minor procedures requiring conscious sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator
Patients who have undergone any recent major surgery must have done so at least 4 weeks prior to starting therapy with cabozantinib, with the following exceptions:\r\n* Vertebroplasty and/or kyphoplasty, which must have been performed at least 1 week prior to starting cabozantinib\r\n* Planned elective surgery unrelated to the patient’s diagnosis of multiple myeloma, such as hernia repair, may be allowed, at the discretion of the principle investigator, as long as it was performed at least 2 weeks prior to starting cabozantinib, and patients have\r\nrecovered fully from this procedure
Patients must have measurable lesion(s) and one or more of the following criteria:\r\n* Failure of surgery to control disease (i.e. positive margins or recurrence of HSIL after surgery)\r\n* Multifocal or extensive disease for which surgery would result in major deformity that is not be acceptable to the patient\r\n* Disease for which surgery would have a risk of functional impairment that is not be acceptable to the patient (i.e. involve partial or complete excision of the clitoris, anus, vagina, or urethra)
Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing
The patient must be a suitable candidate for surgery, in the opinion of the treating physician
Subjects undergoing emergency surgery
Medically inoperable or patient refusal to surgery as defined by any single of the following criteria\r\n* Determined unfit for surgery by thoracic surgeon or radiation oncologist as documented in the medical record\r\n* Pulmonary function tests (PFTs) showing forced expiratory volume in 1 second (FEV1) =< 1.2 L or diffusion capacity of the lung (DLC) < 60%\r\n* Poor exercise tolerance or failed pre-operative cardiac work-up\r\n* Patient refusal to undergo definitive surgery as documented in clinical note by a surgeon, pulmonologist, medical oncologist, or radiation oncologist
Appropriate candidate for breast-conserving surgery based on multi-disciplinary assessment
Subjects are not a candidate for breast conserving surgery
Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease
Able to understand their disease and the exploratory nature of combining surgery and HIPEC for this histology
The planned treatment regimen must be concurrent chemoradiation with carboplatin-paclitaxel followed by surgery
Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or
Cutaneous HNSCC must not be amenable to local treatment modalities, including surgery and/or radiation
Status post first-line therapy with definitive surgery (which provided tissue for pathologic diagnosis) and chemotherapy
Subject not a candidate for surgery;
If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: Major surgery =< 28 days prior to treatment with everolimus.
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
Emergency surgery
Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement
Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Any patient who has had a recent surgery should have recovered from all effects of the surgery and be cleared by their surgeon
Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.
Patients who underwent surgery for a progressive plexiform neurofibroma will be eligible to enter the study after the surgery, provided the plexiform neurofibroma was incompletely resected and is measurable
History of major surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n* Minor surgery within 1 months of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications
In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
Incomplete recovery from acute effects of any surgery prior to treatment.
Treatment must be initiated >= 14 days and < 6 weeks from surgery
Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality.
Medical indication or subject desire to undergo BC surgery prior to completing at least 14 days of treatment with ODM-201.
Patients must have fully recovered from all effects of surgery; patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy; minor procedures requiring “Twilight” sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator
Candidate for definitive cancer surgery as determined by treating physician
The ability for the definitive cancer surgery to be scheduled within 10 days to 12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis – but from start of diet)
Patient is not a candidate for definitive cancer surgery
Definitive cancer surgery is expected to be performed < 10 days or more than 12 weeks post study enrollment as determined by the enrolling physician
Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
Cerebral edema, grade 3 or greater prior to surgery
Planned to get local surgery
Normal serum TSH within 12 months preceding surgery
Has received locoregional therapy to liver (transarterial chemoembolization (TACE), transarterial embolization (TAE), radiation, radioembolization, or ablation) or surgery to liver or other site within 6 weeks prior to the first dose of study drug; minor surgery must have occurred at least 7 days prior to the first dose of study treatment (cycle 1, day 1); subjects must have recovered adequately (i.e., grade =< 1 or baseline) from the toxicity and/or complications from any intervention prior to starting therapy
Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
Plan to proceed to surgery following peri-operative chemotherapy based on standard staging studies per local practice
Pathologically-confirmed invasive breast cancer; if patients undergo upfront surgery, the pathologic stage must be T0-T3, N0-N2a or N3a; if patients receive neoadjuvant chemotherapy prior to surgery, the clinical stage must be T0-T3, N0-N2a or N3a
Documentation of arm volume measurement by perometer prior to axillary surgery
Patients must have local or metastatic recurrence of IBC after prior surgery
Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study
Have adequately recovered from second look surgery to be able to start bevacizumab within 7 weeks of this procedure
Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery will not be eligible
Incurable HPVOC, as defined by:\r\n* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. surgery, radiotherapy or chemoradiotherapy) with no potentially curative option (i.e. surgery or radiation); OR\r\n* Distant metastasis
Patients who are unable to swallow pills or who have undergone surgery that prohibits the absorption of pills in the stomach
Participant has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing; participants with bowel resections at surgery should begin protocol at least 42 days after surgery
Patient must be a surgical candidate with therapeutic goal of eradicating all known disease with one additional surgery; portal venous embolization is permitted to ensure resectability
Any stage, considered candidates for surgery and scheduled for surgery either by robotic or by standard surgical technique
Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred
Has had major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient or compromise the patient’s ability to complete the study
Patient must be cleared for surgery and low/moderate risk for perioperative complications related to general anesthesia
Previous treatment with surgery, radiation, chemotherapy, targeted agents are allowed provided that: \r\n* Chemotherapy/major surgery was administered > 14 days before the start nivolumab\r\n* Minor surgery, radiation, or any targeted agents were administered > 7 days before the start of nivolumab
Gastrointestinal surgery within the previous 3 months
The patient’s refusal to proceed with curative breast surgery has to be documented by the surgeon’s and medical oncologist’s note
Major thoracic or abdominal surgery from which the patient has not sufficiently recovered yet
The patient has elective or planned major surgery to be performed during the course of the clinical trial
Major surgery (e.g. intra-abdominal, intra-thoracic or intra-pelvic) within 4 weeks prior to starting study treatment or lack of recovery from side effects of such procedure; video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can receive study treatment >= 1 week after these procedures
A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after 3 complete cycles of treatment
Meet criteria for neoadjuvant chemotherapy or primary breast surgery, as determined by primary oncologist and surgeon
anticoagulation with inability to stop anticoagulants prior to surgery
Adequate recovery from all recent surgery is required. At least 21-days must have elapsed from the time of any major surgery, including craniotomy/tumor resection. Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
Prior surgery to the same levels of spine
If they have not previously had a video assisted thoracoscopic surgery, and they have a free pleural space to allow for a video assisted thoracoscopy surgery (VATS) procedure, then they must be willing to undergo a VATS for adequate histologic staging
Previous CNS surgery within 2 weeks of treatment, with the exception of biopsy
Any sign of active uncontrolled disease including but not restricted to cardiac disease, infections, hepatitis; any severe chronic disease potentially interfering with the protocol including human immunodeficiency virus (HIV) infection, active hepatitis B or C; it includes major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
PHASE 1: Patients having undergone recent surgery are eligible as long as they are at least 3 weeks from resection or 1 week from stereotactic biopsy, and recovering from any operative or perioperative complications; no measurable disease post resection will be required
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that:\r\n* Systemic therapy was administered >= 7 days before SRS\r\n* Radiation was not to the brain\r\n* Surgery to the brain was >= 7 days prior to SRS and there remains at least one additional brain metastasis that can be targeted with SRS
Patients had craniotomy and surgery to the brain within 7 days from the date of SRS
Patients have unresectable MPM or the patient refuses surgery for resectable MPM
Inability to safely delay surgery by 8 weeks as per surgeon’s discretion
Planned resectional surgery for MPM (extrapleural pneumonectomy [EPP] or pleurectomy and decortication [P/D])
CERITINIB EXCLUSION CRITERIA: Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting capmatinib; video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the study >= 1 week after the procedure
No prior definitive surgery for HNSCC
Subjects who have undergone any recent major surgery must have done so at least 4 weeks prior to starting therapy with DS3032b, with the following exceptions: vertebroplasty and/or kyphoplasty, which must have been performed at least 1 week prior to starting DS3032b; planned elective surgery unrelated to the subject’s diagnosis of multiple myeloma, such as hernia repair, may be allowed, at the discretion of the principle investigator, as long as it was performed at least 2 weeks prior to starting DS3032b, and subjects have recovered fully from this procedure
For patients with rHGG, the patient intends to undergo treatment with the Gliadel® wafer at the time of planned resection (ie, on-study surgery) or has received the Gliadel wafer < 30 days from the date of planned resection.
Patients who have had other surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
PHASE I: Recovery from effects of recent surgery, radiotherapy, or chemotherapy must be demonstrated
Unresolved toxicity from previous anticancer therapy or incomplete recovery from surgery
Prior breast surgery which interrupts communication of the ductal systems with the nipple
Prior treatment for CaP by surgery, irradiation, local ablative (e.g. cryosurgery or high intensity focused ultrasound) or androgen deprivation therapy.
Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
The patient has elective or planned major surgery to be performed during the course of the clinical trial
Macroscopic complete salvage surgery with curative intent (surgery was not performed only for biopsy or palliation); final pathology and imaging must indicate a R0 or R1 resection (no gross disease remaining)
Any patient with gross residual disease following salvage surgery
Patients will not have any other curative therapeutic option, such as radiation or surgery
Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
Major surgery (such as GI surgery) within 6 weeks of enrollment; however, subjects who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications; subjects with clinically relevant ongoing complications from prior surgery are not eligible; the following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
Clinically disease-free after surgery
Patients who have had secondary debulking surgery
Patients with an impending fracture who have had bevacizumab are eligible provided there will be a 3-week window between their last infusion and surgery
Patients must begin treatment as outlined in the protocol within 42 days of definitive surgery (day of surgery is day 0; definitive surgery includes last surgery to resect residual tumor)
Patients must begin treatment within 42 days of definitive surgery (day of surgery is day 0; definitive surgery includes repeat surgeries to resect residual tumor)
Patients will be consented prior to the surgical evaluation/cytoreductive surgery; patients must have less than or equal to 0.5 cm residual disease at the completion of the secondary surgery to be eligible for the study
Entry into the study is limited to no more than 8 weeks from the date of surgery.
Subject must take anticoagulations or antiplatelet agents, including nonsteroidal anti-inflammatory drugs (NSAIDS), that cannot be stopped for surgery
Major surgery (includes any surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment or inadequately healed incision/scar from prior surgery
Requirement for immediate palliative treatment of any kind including surgery
Prior surgery for this cancer
Subjects may have received any other investigational agents or chemotherapy as long as they are eligible for SABR and surgery
Patient must be scheduled for elective major cancer surgery at Fox Chase Cancer Center (FCCC) =< 30 days after first registration\r\n* Elective surgery is defined as:\r\n** Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery AND\r\n** Surgery is not scheduled as urgent or emergent
Status post above elective surgery =< 30 days after first registration\r\n* Elective surgery is defined as:\r\n** Patient was brought from their home (or normal living environment) to FCCC on the day prior to surgery or the day of the index surgery AND\r\n** Surgery was not scheduled/performed as urgent or emergent
Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing
Have had had surgery within four weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Not able to receive the vaccination within 10 weeks following the surgery secondary to a delayed recovery from the surgery
Women must not become pregnant prior to surgery or during the first 3 months after surgery; women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery
Patients who have had previous thyroid surgery
Prior brain surgery is allowed, although a lesion situated in the operative bed would not be selected to receive an experimental dose of SRS treatment; SRS should be delivered 4-6 weeks post-surgery if the patient had a craniotomy for resection of a lesion; enrollment of a patient with the goal of performing SRS outside of the 4-6 post-craniotomy window is at the principal investigator (PI)’s discretion
Has disease which is amenable to radical treatment with surgery or radiation or a combination of treatments
Had surgery within 4 weeks prior to study treatment except for minor procedures (hepatic biliary stent placement is allowed)
History of rectal surgery
Therapy must begin =< 5 weeks after surgery or biopsy
No requirement for immediate palliative treatment of any kind including surgery
Requirement for immediate palliative treatment of any kind including surgery
In the absence of a being treated on a clinical trial, the patient would be recommended to receive neoadjuvant chemoradiation followed by curative intent surgery
Patients with oligometastatic NSCLC (defined as =< 4 metastatic sites of disease), all treated with definitive intent using radiation, surgery, radiofrequency ablation (RFA), chemoradiation therapy, other definitive modalities or combinations of these
Before administering liposomal doxorubicin, patients must wait 4-6 weeks after surgery
Patients will not have any other curative therapeutic option, such as radiation or surgery
All adverse events grade =< 2 related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved, except for alopecia or neuropathy; patients are eligible for enrollment if they have had no surgery in the prior 6 weeks (minor surgical procedures such as skin biopsies and port placement done on an outpatient basis do not require a waiting period)
At least 2 weeks must have elapsed from any prior surgery
Requirement for immediate palliative treatment of any kind including surgery
Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team
Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.
Patients must be stable from cardiopulmonary and hemodynamic standpoints to continue with prolonged surgery and anesthesia
Patients found to have non-gynecologic, uterine, or breast primary at surgery
Patients with core body temperature > 37 degrees Celsius (C) at completion of cytoreductive surgery and prior to HIPEC
Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 7 days must have elapsed prior to the day of protocol treatment
COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI
At least 2 weeks must have elapsed from any prior surgery
Requirement for immediate palliative treatment of any kind including surgery
Perineural invasion (PNI) on transoral robotic surgery (TORS) resection of the primary cancer
Patient is medically unfit for surgery or is deemed surgically unresectable by head and neck (H&N) surgeon within 60 days prior to enrollment, or patient refusal of surgery
Previous thyroid surgery
Becomes pregnant before surgery or at any time while on study
Subjects having undergone recent resection or biopsy of an intracranial tumor will be eligible as long as all of the following conditions apply: \r\n* First dose of cabozantinib occurs at least 28 days after surgery, and the subject has recovered from the effects of surgery
Macroscopic residual disease after surgery
Symptomatic patients in need of surgery to the “target” lesion
Patients may not have had any prior tumor treatment except for surgery, and must have adequately recovered from surgery
The patient is able/eligible to undergo treatment with transoral surgery (transoral laser microsurgery [TOLM] or transoral robotic surgery [TORS]) with or without neck dissection and with or without adjuvant radiation therapy or chemoradiation
Patients who have undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment; NOTE: All toxicities and/or complications must have recovered to baseline or grade\r\n1 prior to the initiation of ADXS11-001 study therapy; sponsor must be consulted prior to enrolling subjects on the study who recently had a major surgery or have new artificial implant, and/or devices
Resected patients should begin treatment within 24 weeks of surgery, once adequately healed as determined by the treating physicians
At least 4 weeks post-surgery, and must be at least 3 months post-radiation therapy, with resolution of related toxicities
Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
Requirement for immediate palliative treatment of any kind including surgery
It is strongly encouraged that all patients have metallic clips placed in the tumor prior to neoadjuvant therapy in order to facilitate evaluation for microscopic disease at the time of surgery; placement of clips is particularly encouraged for patients being considered for breast conserving surgery
The patient is medically suitable candidate for preoperative chemotherapy and surgery in the judgment of the treating physicians
Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Any patient with surgery scheduled < 7 days after biopsy
Patients must have undergone breast-conserving surgery
The patient must be enrolled on the study within 42 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
Patients who have had non-biopsy surgery in the last 10 days
Surgery intent within 4 weeks
If markers or clips were placed at the time of surgery, patient must be able to start treatment within 12 weeks after lumpectomy or re-excision for adequate margins.
If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery.
Requirement for immediate palliative treatment of any kind including surgery
Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
Patients must begin partial brain radiotherapy and temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the surgery in which pathology was confirmed; if a patient elects to have a second surgery to obtain further resection, they will remain eligible for treatment as long as no treatment has been initiated prior to this surgery; in this case, initiation of treatment must begin within 2 to 6 weeks from the last surgery; tissue collection is preferred but not mandatory; patients may have radiotherapy administered at outside facilities; radiotherapy must be given within 2 days of lapatinib initiation and by external beam to a partial brain field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy; stereotactic radiosurgery and brachytherapy will not be allowed
Patients must have fully recovered from all effects of surgery; patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy; minor procedures requiring “Twilight” sedation such as endoscopies or mediport placement may only require a 24 hour waiting period, but this must be discussed with an investigator
Subjects with recurrent or progressive glioma who have failed standard therapy with surgery and/or radiation for whom local therapy has been requested by the neuro-oncologist. This treatment will be offered as an option for those patients where neither surgery or repeat radiotherapy is advised by the multidisciplinary team. OR Patients with metastatic brain cancer that has progressed despite prior radiotherapy and local therapy is requested by the oncologist. This treatment will be offered as an option for those patients where surgery is not indicated and discussed with the potential options for repeat radiotherapy or salvage radiosurgery by the multidisciplinary team.
Lung function capacity capable of tolerating the proposed lung surgery
Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g, gastric bypass surgery, gastrectomy)
Patients with resectable disease will be eligible for participation if, and only if, they have comorbidities precluding surgery or refuse to undergo an operation following a multi-disciplinary discussion involving surgical oncology, medical oncology, and radiation oncology; this discussion will actively involve the patient and reinforce that surgery is the current standard of care for such patients
For clinically stage II patients, the patient must have been evaluated by a thoracic surgeon, and deemed medically or technically inoperable, or the patient must refuse surgery
All patients who have surgery performed must have a cranial MRI pre-operative and post-operative (should be done within 72 hours of surgery or within 21 days following surgery)
Patients must have recovered from the surgery
Patients must have undergone debulking surgery with peritonectomy and have been allowed at least 4 weeks to recover prior to receiving chemotherapy
Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization within 4 weeks of PV-10 administration.
The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
Histologic confirmation of cancer will be required by biopsy, prior surgery, and re-biopsy at the discretion of the treating physician
The attending surgeon considers the mass to be amendable to robotic assisted surgery
No prior systemic therapy or iodine I 131 (I131) or chemoembolization treatment after surgery
Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
Participant is able to undergo surgery (planned lobectomy or wedge resection)\r\n* Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
Previous surgery for this lung or mediastinum tumor
Medically fit to undergo radical surgery as per treating surgeon's discretion
Patients must be deemed to be in adequate health to undergo major surgery (pancreaticoduodenectomy)
interval of ? 14 days between end of surgery and start of protocol therapy for patients who have undergone surgery for recurrent disease.
Elective or planned major surgery to be performed during the course of the trial
Minor surgery within 7 days of first dose of STA-9090
surgery was completed ?4 weeks prior to baseline
History of gastric or small bowel surgery.
Time between primary surgery and randomization > 3 months.
Repeat surgery for recurrence of disease
Prior areolar or breast surgery which interrupts communication of the ductal systems with the nipple
Plan to begin partial brain radiotherapy within 24-72 hours after beginning AQ4N, and within 35 days (5 weeks) of the surgery, or if surgery cannot be performed, the biopsy that confirms GBM diagnosis. Radiation therapy must be given by external beam to a partial brian field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy over 6 weeks.
Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Previous breast surgery with the exception of biopsy
Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive diagnostic surgery (Day 0)
Subjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors with curative intent.
Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
Who have had non-biopsy surgery in the last 10 days
Standard preoperative evaluation is performed and deemed satisfactory to proceed to surgery as per their treating urologist
Patients must have undergone surgery and must not have had any further treatment following surgery. Patients must have undergone surgery of their glioblastoma (GBM), and must not have had any further treatment following surgery. A minimal interval of 7 days between the day of surgery and the day of inclusion should be respected; a maximal interval of 31 days between the day of surgery and the day of inclusion should be respected; the patient should have fully clinically recovered from the surgery. (For stage 2: radiation with concurrent and adjuvant EDO-S101 only)
Patients must undergo surgery and must not have further treatment. (For MTD expansion cohort only)
Resective surgery within 2 months prior to the initial pre-treatment AMT-PET scan
Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
The subject must have a complete removal of the primary HNSCC lesion with negative gross and microscopic margins; documentation of margins by frozen sections at surgery is recommended; patients who have already had surgery and have available banked tumor samples can be enrolled AFTER surgery
At least a 12 week interval should have elapsed between prior surgery, radiation therapy, chemotherapy or any other treatment and the first vaccination; patients should have recovered from surgery and adjuvant treatment
Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable
Surgery or local prostatic intervention (excluding a prostatic biopsy) less than 28 days of Cycle 1 Day 1.
Part 1 patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
Surgery within 21 days prior to study entry.
Patient has at least one of the following:\r\n* Pathologic N1-3\r\n* Pathologic T3\r\n* Neoadjuvant chemotherapy and did not achieve pathologic response at time of surgery
Patients who require local palliative measures such as XRT or surgery
Subjects who have undergone major surgery within 28 days of study day 1; vertebroplasty and/or kyphoplasty, which must have been performed at least 1 week prior to starting AMG-232 + KRd
Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
The subject must have received maximal debulking surgery and undergo radiotherapy concomitant with temozolomide (45-70 gray [Gy])
Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at this time, then it should be performed at least 10 days following surgery before study enrollment; false positive cytology can occur within 10 days of surgery; Note: patients with positive CSF cytology obtained prior to 10 days after surgery may have cytology repeated to determine eligibility
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical diagnosis
Subjects must be medically fit to undergo surgery determined by the principal investigator (PI)
Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay required for minor procedures (e.g., tumor fine-needle aspiration [FNA] or core biopsy, venous access device placement)
Ibrutinib should be held at least 3 to 7 days pre- and post-surgery, depending upon the type of surgery and risk of bleeding
Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery and the subject has recovered from surgery
Participants receiving the following medications or treatments within the 6 weeks (42 days) prior to consenting; these medication and treatments may not be re-started at any time throughout the study in order to be remain eligible:\r\n* Breast tumor resection surgery (reconstructive surgery permitted)\r\n* Chemotherapy\r\n* Radiation therapy\r\n* Allergy desensitization injections\r\n* Growth factors (Procrit, Aranesp, Neulasta)\r\n* Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)\r\n* Any investigational medication
Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively
Expected communication between ventricles and resection cavity as a result of surgery
Participants must have had prior debulking surgery.
Recent (i.e., ? 6 weeks) history of abdominal surgery or peritonitis
Children less than 8 months of age at the time of definitive surgery with or without measurable radiographic residual tumor with M0 stage medulloblastoma will be eligible for study entry
Evaluation of lumbar CSF cytology (cytospin preparation for microscopic evaluation) must be performed either pre-operatively or at least 10 days after definitive surgery unless contraindicated
Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
A history of prior trans-urethral surgery requires cystoscopy for evaluation before study entry to rule out stricture
Prior significant rectal surgery (hemorrhoidectomy is acceptable)
Previous urethral sling, artificial urinary sphincter or penile prosthesis surgery
Subjects must have recovered from surgery before study registration
Therapy must begin between 21 days (3 weeks) and 42 days (6 weeks) after the most recent brain tumor surgery (resection or biopsy)
Patients who require WBRT or surgery at the time of enrollment
History of sinus or ear surgery, excluding myringotomy or ear tubes
Patients must be willing and able to undergo a pre-surgery biopsy and wait 2 weeks before their debulking surgery; NOTE: consented patients with subsequent inadequate biopsy material will not receive INCB024360 or be analyzed and will be replaced; the study will be stopped if adequate tissue is not obtained in more than 2/3 of paired samples with a maximum accrual of 18 patients
Patients who are not currently candidates for radical cystectomy (e.g. patient refuses surgery, comorbidities preclude major surgery, etc.)
Not likely curable with surgery alone
Recovery from effects of recent surgery, radiotherapy, or chemotherapy
Patients who have had prior chemotherapy, radiotherapy, or surgery with curative intent for HNSCC
Able to understand their disease and the exploratory nature of combining surgery and HIPEC for this histology
Requirement for immediate palliative treatment of any kind including surgery
Current participation in another clinical study involving treatment with medications, radiation or surgery, or prior participation in this study
Current participation in another clinical study involving treatment with medications, radiation or surgery, or prior participation in this study
Patients must have measurable advanced disease, that is not resectable by surgery; all sites must be assessed within 4 weeks prior to randomization
Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction
Patients should be found unresectable by a preliminary Ear, Nose, and Throat (ENT) evaluation or have refused surgery
Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.
Patients may be optimally or suboptimally debulked after surgery
Patients must have recovered from prior surgery based on treating physician's discretion
Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization
At least 4 weeks after surgery or radiotherapy
Not curable by surgery.
Recovery from effects of recent surgery, radiotherapy, or chemotherapy:\r\n* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\r\n* Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted and immunologic agents (including small molecules and murine monoclonal antibodies), must be discontinued at least three weeks prior to registration; chimeric or human or humanized monoclonal antibodies (including bevacizumab) or vascular endothelial growth factor [VEGF] receptor fusion proteins (including VEGF tartrate-resistant acid phosphatase [TRAP]/aflibercept) must be discontinued for at least 8 weeks prior to registration\r\n* At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy, thoracotomy, video assisted thorascopic surgery [VATS]; minor: central venous access catheter placement, ureteral stent placement or exchange, paracentesis, thoracentesis)
Patients who have elective or planned major surgery to be performed during the course of the clinical trial; minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy is permitted
Subject is scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
Avastin use within 30 days prior to surgery.
Subject is scheduled for another surgery during the first 6 months following surgery (not including stoma closure ,placement of port for chemotherapy or ureter stent insertion).
Subject requires additional unrelated anastomosis during the surgery.
Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
Previous TransOral Robotic Surgery (TORS) to the oropharynx
At least 4 weeks must have elapsed since the patient underwent any major surgery (eg. MAJOR: laparotomy, laparoscopy, thoracotomy, VATS [video assisted thorascopic surgery]); there is no restriction on MINOR procedures: (eg. central venous catheter placement, ureteral stent placement or exchange, tumor core or fine-needle aspirate [FNA] biopsy)
At least 7 days since any minor surgery such as port placement
If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery
Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
Surgery must have confirmed the recurrence
Histologically confirmed hepatocellular carcinoma not amenable for management with curative intent by surgery or local therapeutic measure;
Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
Patients should be suitable candidates for surgery and chemotherapy
Has had major surgery within 3 weeks prior to enrollment (a percutaneous biopsy, pleural catheter insertion, placement of central venous catheter or other minor procedure are permitted)
SUB-PROTOCOL AIM A: Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) =< 4 weeks prior to registration or failure to recover from side effects of such surgery; exceptions: port placements, nephrectomy, tumor biopsies, and minor surgeries
Has undergone prior surgery at the tumor site or the index tumor has undergone previous surgery or ablation treatment
Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
Surgery completed at least 28 days before randomization;
Expected to have surgery during study period;
Completely removed melanoma by surgery performed within 12 weeks of randomization
Treatment directed against the resected melanoma that is administrated after the surgery
Patients who have received prior chemoradiation, radiation, and/or surgery in the potentially curative setting are eligible as long as 3 months has elapsed since the end of the potentially curative treatment ended
Prior rectal surgery preventing insertion of the TRUS probe.
Current participation in another clinical study involving treatment with medications, radiation or surgery, or prior participation in this study
Breast surgery planned
Had a major surgery or significant trauma within 4 weeks before the start of anetumab ravtansine
have an elective or a planned major surgery during the course of the trial
Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression
Are scheduled for debulking surgery during the study
Subjects with ductal carcinoma in situ (DCIS)  that express HER-2 on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or needle-localized (NL) surgical biopsy with positive margins
The patient must be a suitable candidate for surgery, in the opinion of the treating physician
Patients with a history of prior pituitary surgery must be at least 30 days post-surgery to be eligible for inclusion in this study.
Patients with de novo Cushing's disease can be included only if they are not considered candidates for surgery.
Patient must be eligible for abdominal surgery
Have significant loss of gastrointestinal organs, except for appendix, due to surgery
Patient has EITHER:\r\n* A Kattan nomogram predicted probability of being disease free 5 years after surgery of < 60%, OR\r\n* A Gleason sum >= 8
Any surgery, where general anesthesia was administered, must have occurred at least 7 days prior to study enrollment
Any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) that is completed within 12 hours prior to first dose of study drug, or ongoing impairment of hemostasis as a result of one of these procedures
Any prior melanoma treatment other than surgery or regional irradiation
Subjects who have undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: \r\n* Prior to initiating therapy, 4 weeks must have elapsed since surgery; \r\n* Subjects must have recovered from surgical-related trauma; \r\n* Wound healing needs to have occurred
Must have completed definitive resection of primary tumor. The last surgery for breast cancer must have been completed at least 14 days prior to registration for protocol therapy.
Patients must not have had major surgery within 6 weeks prior to enrollment on the high risk stratum; patients with history of recent minor surgical procedures (vascular catheter placement, bone marrow evaluation, laparoscopic surgery, liver tumor biopsy) will be eligible
Prior curative-intent surgery at least 3 months prior to the nodal recurrence.
Adequate recovery from all recent surgery is required; at least 1 week must have elapsed from the time of a minor surgery; at least 21 days must have elapsed from the time of a major surgery. Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
Resolving hemorrhagic changes related to surgery.
Prior surgery or radiotherapy within 14 days of therapy.
Pregnant at time of surgery
Emergency surgery for abdominal indications
• Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;
Subject undergoing cardiothoracic surgery is not allergic to protamine; and
Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;
Subject receiving antiplatelet medications within 5 days prior to surgery;
Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;
Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
If patients underwent surgery, and chemotherapy is indicated after surgery either as adjuvant or to treat residual disease, study treatment should be initiated within 8 weeks of surgery
Patient must have had their primary tumor treated with surgery and/or radiation
Patients must not have disease that is currently amenable to surgery; prior surgery is allowed no less than 6 weeks prior to study entry
Patient desire to undergo breast surgery
Post surgery:\r\n* Must be a minimum of 14 days from surgery before treatment may be initiated\r\n* Craniotomy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration\r\n* Post tumor resection, all patients must have a post-operative magnetic resonance imaging (MRI) done no more than 72 hours after surgery; if post-op MRI was not completed within this time frame, a MRI must be completed > 4 weeks (+/- 7 days) after surgery, but before initiation of radiation treatment in order for an accurate assessment to be done post-radiation
Patients must be medically fit enough to undergo surgery as determined by the treating medical and surgical oncology team
Planning to undergo breast-conserving surgery
Preference for mastectomy instead of breast-conserving surgery
Cleared by the primary medical doctor for surgery
Last surgery > 10 weeks from enrollment
Surgery less than two weeks before enrollment
Major surgery (such as GI surgery) within 6 weeks of enrollment; however, subjects who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications; subjects with clinically relevant ongoing complications from prior surgery are not eligible; the following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
Surgery within 4 weeks prior to study treatment except for minor procedures: NOTES: Hepatic biliary stent placement is allowed. Subject must have adequately recovered from the toxicity and/or complications of major surgery prior to study registration, as determined by the treating physician.
Prior therapy or surgery (3 to 10 weeks depending type)
Major surgery within 14 days prior to start of treatment; no time limitations after minor surgery (e.g.: core biopsy or central line placement)
Patients must be recovered from effects of recent surgery (28 days must elapse between surgery and the start of treatment with cabozantinib)
Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy; minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period
Any minor surgery or core biopsy completed >= 1 week prior to randomization and patient must have fully recovered from the procedure; Note: insertion of a vascular access device is not considered major or minor surgery
At least 4 weeks must have lapsed since major surgery (e.g., laparotomy, laparoscopy, thoracotomy, video assisted thoracoscopy) prior to study treatment initiation
Patient is currently participating in or has participated in a study of an investigational systemic agent to treat MCC; or is using an investigational device within 4 weeks of the first dose of treatment\r\n* NOTE: if patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy\r\n* Toxicity from surgery or associated interventions that has not recovered to =< grade 1 is allowed if it meets the inclusion requirements for laboratory parameters
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
At least 3 months have elapsed between any prior brain radiotherapy and initiation of study therapy (unless the subject recently underwent surgery for proven or suspected disease recurrence, the histology of the most recent surgery demonstrated recurrent/progressive/persistent malignant glioma, Gliadel wafers were not placed during the most recent surgery, neither convection enhanced delivery nor catheters for infusion of chemotherapy were use during the most recent surgery, and radioactive seeds were not placed during the most recent surgery)
Patients will have cytoreductive surgery as part of their routine care for recurrent tumor
Patients must not have had prior ipsilateral breast-conserving surgery or total mastectomy and be eligible for neoadjuvant treatment
Patients who have not recovered from serious adverse events (as determined by treating doctor of medicine [MD]) related to surgery
Patients who have recurrences that are amenable to potentially curative treatment with radiation therapy or surgery
No defined washout period from major or minor surgery is required but incisions must be fully healed
Any medical condition that precludes the surgery necessary to administer DNX-2401 into the tumor using the cannula
No history of bariatric surgery
Unresectable disease or subject refused surgery.
Subjects who underwent surgery for a progressive plexiform neurofibroma will be eligible to enter the study after the surgery, provided the plexiform neurofibroma was incompletely resected and is evaluable by volumetric analysis
Recurrent or persistent (after the failure of chemotherapy) disease that cannot be treated with surgery or radiotherapy;
No contraindications to limb-sparing surgery; patient should be evaluated by a surgeon who specializes in sarcoma resections prior to study enrollment to ensure patient (pt) is a candidate for limb-sparing surgery
If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications
History of major/minor surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n* Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications; in addition complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Coronary artery bypass graft surgery
Surgery or local prostatic intervention within 4 weeks of the first dose; in addition, any clinically relevant issues from the surgery must have resolved prior to cycle 1, day 1
COHORT A: Patients with underlying heart conditions who are deemed ineligible for surgery
Surgery: >= 3 weeks from major surgery; if recent craniotomy, adequate wound healing must be determined by neurosurgical team
Major surgery (includes surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment
Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Eligible to undergo excisional surgery such as pleurectomy/decortication (P/DC) or any other mesothelioma surgery.
Previous laryngeal surgery
Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemoradiation as specified in the protocol
Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
Achieved a gross total or sub-total resection at time of surgery
Patients with brain metastasis are eligible for participation ONLY if they have been treated with definitive surgery or radiation (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 12 week interval
Must have completed definitive resection of primary tumor. The most recent surgery for breast cancer must have been completed at least 14 days prior (but no more than 84 days prior) to study registration. NOTE: Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however participants with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy. Participants with margins positive for lobular carcinoma in situ (LCIS) are eligible. Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable.
For radiation required prior to surgery, the participant must register within 84 days of surgery. Also, participants in this situation would not be required to have additional post-mastectomy radiation therapy.
For those participants who do not require radiation, registration must be within 84 days of surgery.
Margin negative surgery
For subjects with two breasts, they must have had a bilateral mammogram prior to surgery
Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
Gross residual tumor or positive margins after surgery that is un-excised, as radiation dose in the study will be limited to 60 Gy.
HNSCC and cSCC cannot be curable by surgery and/or radiation therapy
Undergoing laparoscopic or minimally invasive surgery
No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Surgery or local prostatic intervention within 30 days of the first dose; in addition, any clinically relevant issues from the surgery must have resolved prior to enrollment
Presence of any of the following risk factors after surgery:\r\n* Any positive surgical margin\r\n* Adenopathy below the clavicles
Requirement for immediate palliative treatment of any kind including surgery
Patients may have received prior surgery (for both the primary and stage IV disease); all adverse events associated with prior surgery must have resolved to =< grade 1 prior to registration
REGISTRATION TO SURGERY (ARM S)
Patient must be registered/randomized to Step 2 within a maximum of 7 weeks following surgery
Patients with recent resection for recurrent disease must have recovered from the effects of surgery and should not start treatment for at least 28 days after surgery
4 weeks (28 days) from any radiation treatment, stereotactic radiosurgery, conventional surgery, or chemotherapy
Patients may have received prior surgery; however, at least 21 days must have elapsed since completion of surgery and the patient must have recovered from all side effects
Scheduled for surgery during the study.
Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.
Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
Patients should have completed any major surgery >= 4 weeks prior to registration and must have completed any minor surgery >= 2 weeks prior to registration; patients must have fully recovered from the procedure\r\n* The following are examples of procedures considered to be minor: port placement, laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and dental extraction procedures\r\n* Insertion of a vascular access device, thoracentesis, paracentesis, and endoscopic ultrasonographic procedures are not considered to be major or minor surgeries
Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment
Requirement for immediate palliative treatment of any kind including surgery
Surgery or irradiation ? 4 weeks prior to randomization
At least 2 weeks must have elapsed from any prior surgery
Requirement for immediate palliative treatment of any kind including surgery
Scheduled for radical prostatectomy surgery
Major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant systemic disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study
Patient has failed to recover from any prior surgery within 4 weeks of study entry
Patients must have recovered from prior treatment regimens, e.g. surgery, radiation
Minor surgery < 2 weeks from the start of treatment; (insertion of a vascular access device is not considered major or minor surgery)
An interval of no more than 12 weeks between the date of surgery and the date of randomization
Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
Any surgery (including diagnostic laparoscopy and/or biliary +/- duodenal palliative bypass for inoperable PC) within the 2 weeks prior to day 1 of study protocol
Therapy must begin =< 5 weeks after surgery
At least 4 weeks and recovery to grade 0-1 from reversible effects or prior surgery (i.e., incisional pain, wound drainage)
Patient has failed to recover from any prior surgery within 4 weeks of study entry
Patients having undergone recent resection of their glioblastoma (within 5 weeks prior to registration) must have recovered from the effects of surgery; for CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration\r\n* Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative or intra-operative MRI scan (or CT scan for patients with non-compatible devices) must be performed prior to registration and should be within 96 hours post surgery (although 24 hours would be optimum)
Patients may have received Gliadel during surgery
STEP 2 ENROLLMENT AND RANDOMIZATION: the patient must be a suitable candidate for LCT (radiotherapy and/or surgery) to every site of disease, as determined by the treating physician(s); consultation with a multidisciplinary team, including a medical oncologist, radiation oncologist, and thoracic surgeon, is encouraged but not required
Patient must not have had radiation therapy, minor surgery, or tumor embolization with 14 days prior to the first dose of pazopanib
Patients who have not recovered from prior surgery
Incomplete healing from previous oncologic or other major surgery
Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report
Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed.
Cohort 1: Patients must have undergone surgery or biopsy alone (no postoperative radiation or chemotherapy) and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression (no progression from the initial surgery/biopsy)
A candidate for curative surgery
Surgery within 2 weeks prior to dosing
Less than 4 weeks from surgery or insufficient recovery from surgical-related trauma or wound healing
Patients expected to get surgery.
Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis, or at the time of clinically detected nodal and/or in-transit recurrence; patients must undergo biopsy (punch) or open biopsy (if done as part of a clinically indicated baseline diagnostic procedure) within 14 days of entry into the study; lymphadenectomy/definitive surgery will be performed after at least 2 and generally not longer than 4 weeks of induction HDI-ipilimumab therapy; additional delays for definitive lymphadenectomy/surgery are allowed if clinically indicated while awaiting the resolution of potential adverse events from HDI-ipilimumab therapy
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to randomization in the study.
Patient has failed to recover from any prior surgery within 4 weeks of study entry
Saw palmetto administered with the intent to treat the patient’s malignancy within 1 week of degarelix injection for Cohorts 1, 2, and 4, and for within 1 week of surgery for Cohort 3
Patients must be a candidate for surgery
History of gastrointestinal perforation within 12 months of randomization, except for gastrointestinal (GI) perforation related to a primary colorectal tumor that has subsequently been fully resected; subjects would be eligible if >= 4 weeks have elapsed from the time of surgery to start date of chemotherapy on protocol and >= 6 weeks have elapsed from time of surgery to first dose of bevacizumab; the subject must have recovered from the effects of the surgery (e.g. wound is healed, no active infection, no drains, etc.)
Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed propranolol and have stable vital signs confirmed
Patients who have had prior cranial surgery are eligible, provided that there is evidence of measurable residual or progressive lesions, and at least 2 weeks have passed since surgery; if a patient has surgical resection followed by WBRT, then there must be evidence of progressive CNS disease after the completion of WBRT
Patients with an intact colon/rectum, except for clinical polyposis, and prophylactic surgery is being considered as a stratification site.
Biliary obstruction, biliary stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
History of gastrointestinal (GI) surgery within the past 28 days; if > 28 days since GI surgery, must have confirmation of complete healing before initiating treatment with study drug
Subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy
Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy
Subjects with chordomas must be considered to have high risk disease as defined by:\r\n* Local recurrence after surgery alone\r\n* Prior intralesional resections\r\n* Unplanned incomplete resections\r\n* Tumors are unresectable or at best marginally resectable based on locally advanced stage, and\r\n* Patients who decline surgery due to excessive morbidity and would otherwise receive non-operative treatment with radiation and/or medical management if not treated on clinical trial
Patients with a history of atherosclerotic coronary artery disease that required bypass surgery may only be enrolled provided that bypass surgery occurred at least one year prior to enrollment and after consultation with a cardiologist to determine stability of disease
Women with prior radiotherapy to the pelvis or retroperitoneal surgery
Appropriate candidate for surgery
Participants need not have measurable disease; lesion may be primary or recurrent after prior surgery; patient tumor status:\r\n* Status post biopsy only and no further surgery planned\r\n* Status post resection with gross residual disease\r\n* Status post grossly complete resection but with margins positive or close (=< 10 mm)\r\n* Status post biopsy and patient to have additional surgery and radiation
Patients will be ineligible if surgery and chemotherapy was completed >= 20 weeks from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse of prior ipsilateral breast cancer; surgery can exceed 20 weeks if the patient undergoes chemotherapy following surgery
Major surgical procedure or any radiation therapy within 4 weeks of treatment, minimum rest period is 28 days post surgery; maximum rest period 56 days post surgery
Patient has undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment; NOTE: all toxicities and/or complications must have recovered to baseline or grade 1 prior to the initiation of ADXS11-001 study therapy; sponsor must be consulted prior to enrolling patients on the study who recently had a major surgery or have new artificial implant, and/or devices
Incomplete healing from previous oncologic or other major surgery
Patients who have undergone major surgery (including open biopsy, thoracotomy, organ resection, exploratory laparotomy, arteriovenous grafts) < 28 days prior to enrollment will have bevacizumab dosing delayed
Patients with prior abdominal surgery within 30 days prior to entering the study
Patients with evidence of spontaneous hemorrhage greater than 0.5 cm unrelated to surgery
Subject has had prior cytoreductive surgery yielding tumor for lysate preparation
Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing; subjects with bowel resections at surgery who enroll in cohort 3 will begin protocol at least 42 days after surgery if debulking surgery had comprised of bowel resection or other bowel surgery
Treatment with breast conserving surgery
Systemic chemotherapy prior to final breast conserving surgery
Major surgery (e.g., requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound), or surgery planned during the time the patient is expected to participate in the study. Note: patients with planned surgical procedures to be conducted under local anesthesia may participate.
Following surgery, the patient must have received external beam radiotherapy (58-66 Gy in 2 Gy fractions, 5 days per week) with concomitant cisplatin starting within 8 weeks of surgery. A brief delay in the initiation of radiotherapy following 8 weeks post-surgery due to administrative reasons (e.g., start of RT on Mondays) may be permitted by the Medical Monitor. The cumulative dose of cisplatin the subject received must be > 150 mg/m2. Protocol therapy must be initiated within a period of 4-8 weeks (28-56 days) following the end of RT.
History of surgery within last 28 days
Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer
Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer; FIGO stage III and IV defined surgically at the completion of initial abdominal surgery and with appropriate tissue available for histologic evaluation. The minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking.
Patients must be entered no later than 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction.
Patients with or with anticipation of invasive procedures as defined below: Major surgical procedure within 28 days of initiating bevacizumab or major procedures anticipated during the course of the study. This includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery.
For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.
Patient must be at least two weeks post any brain surgery (whether stereotactic biopsy, open biopsy or resection) at the time of randomization
prior significant rectal surgery (hemorrhoidectomy is acceptable; rectal resection/fissure repair are excluded);
Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers
Randomization within 12 weeks of surgery
Prior therapy for melanoma except surgery
Patient must be suitable candidates for surgery.
Patients with contraindications to surgery;
Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
Patients must begin treatment as outlined in the protocol within 31 days of definitive surgery
Estimated blood loss > 2 liters during surgery
Patients who are candidates for curative surgery or radiotherapy
Patients are only eligible if complete tumor resection is not feasible, or if a patient with a surgical option refuses surgery; patients must have measurable residual tumor present; for the purpose of this study a measurable lesion will be defined as a lesion of at least 3 cm measured in one dimension; evidence of recurrent or progressive disease is NOT necessary; patients must be at least 21 days from surgery, if performed, prior to receiving their first dose of study drug
Patient must have the presence of residual resectable disease for which surgery is clinically indicated, and will be performed at All Children’s Hospital
Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and >= 14 days has passed since the operation; patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence
Patients must have fully recovered from all effects of surgery; patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy; minor procedures requiring “twilight” sedation such as endoscopies or Mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator
Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,
Major surgery of the spine in same region as the index vertebra(e) was performed within 3 months before enrollment,
Major elective surgery to the spine in same region as the index vertebra(e) is planned within 1 month following the ablation and cement procedure,
Requires upper and lower limb surgery that will affect functional outcomes,
For subjects receiving adjuvant therapy only, time between definitive surgery and randomization must be ? 12 weeks. Definitive surgery may include secondary interventions (e.g. to clear inadequate surgical margins)
VS surgery determined clinically necessary by the treating physician and scheduled within 4 weeks
Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
28 days for cytotoxic chemotherapy, immunotherapy, whole brain radiotherapy, anticonvulsive therapy, stereotactic radiosurgery and major surgery
Tumor must be surgically resectable and curable with conventional surgery
Interval of at least 3 weeks after biopsy or open surgery and able to begin study treatment.
Patients with surgery for a prior ipslilateral lung cancer are excluded
Adequate recovery from recent surgery; at least one week must have elapsed from minor surgery (placement of venous access device or fine needle aspiration) and at least 4 weeks from major surgery
Prior surgery for the IHC; (liver resection is not allowed)
At least 2 weeks must have elapsed from any prior surgery
Requirement for immediate palliative treatment of any kind including surgery
Recent history (? 3 months) or ongoing partial or complete bowel obstruction unless due to disease under study and corrected with surgery.
Previous surgery or radiofrequency ablation (RFA) to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
Pts who are medically unfit to tolerate surgery
Patients with carcinoma of the cervix must have advanced disease not amenable to curative surgery and/or radiation therapy
Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery & subject has recovered from surgery
Candidate for curative surgery or definitive chemoradiation
Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
Completed their last dose of chemotherapy or had their last cancer surgery more than 10 weeks, whichever came later, prior to randomization.
Prior pancreatic surgery
Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
At the time of day 1 of the study, patients must be at least 3 weeks since surgery.
REGISTRATION #2: SURGERY
Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor
Patients with an obstructive synchronous colorectal tumor requiring up-front surgery or chemoradiation
SURGERY:
Patient must be willing to undergo surgery at MUSC within 4-8 weeks of completing chemoradiation
Inclusion Criteria:\n\n        3.1.1 First-line treatment of metastatic colorectal cancer with 3 or more metastases\n        3.1.2At least 10 cycles of combination therapy with an oxaliplatin or irinotecan based\n        regimen per institutional preference (patients may receive 6 cycles, go to surgery, then\n        complete 4 cycles, they may complete all 10 (or more) prior to surgery, or receive any\n        combination as long as they receive at least 10 cycles. ) 3.1.3 Resection or ablation of\n        all metastatic sites that have not achieved complete response with perioperative therapy\n        (regimen). The sequencing of resection, ablation, and 10-12 cycles of combination therapy\n        (regimen) with an oxaliplatin or irinotecan based regimen may be performed according to\n        standard institutional procedure.\n\n        3.1.4 Patients achieving a complete response in a metastatic site by stereotactic body\n        radiation are eligible if the site was not easily accessible by surgery or ablation and a\n        complete response was achieved.\n\n        3.1.5 No severe, uncontrolled concurrent illness that would interfere with protocol\n        therapy.\n\n        3.1.6 No known CNS disease 3.1.7 ECOG Performance Status 0-2 3.1.8 No chemotherapy or\n        radiation therapy within last 3 weeks 3.1.9 For patients who had 3 months of perioperative\n        therapy (regimen), then surgery, then 3 months of therapy (regimen), patients must be off\n        therapy for no more than 8 weeks prior to randomization. For patients who had all their\n        therapy and then surgery, they must be no more than 8 weeks from surgery prior to\n        randomization.\n\n        3.1.10 No concurrent anticancer therapy. 3.1.11 Absolute neutrophil count ? 1,500/uL, Hgb >\n        9.0 g/dl, platelet ? 100,000/uL.\n\n        3.1.12 Total bilirubin ? 1.5x upper limit of normal (ULN) and AST or ALT ? 5x ULN; 3.1.13\n        Creatinine < 1.5 x ULN 3.1.14 Life expectancy of at least 12 weeks. 3.1.15 Age ? 18 years\n        3.1.16 Women of childbearing potential must have a negative pregnancy test. 3.1.17 Men and\n        women of childbearing potential must be willing to consent to using effective contraception\n        while on treatment and for at least 3 months thereafter.\n\n        3.1.18 Voluntary written informed consent.\n\n        Exclusion Criteria:\n\n        3.2.1 Residual metastatic disease after resection/ablation 3.2.2 Clinically significant\n        cardiac disease (e.g., uncontrolled hypertension [blood pressure of >160/90 mmHg on\n        medication], history of myocardial infarction within 6 months,), New York Heart Association\n        (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia.\n        Patients with an atrial arrhythmia must have this condition well controlled on stable\n        medication. Patients with current or recent (within 6 months) unstable angina are also not\n        eligible. Documentation of cardiac medical history to be provided.\n\n        3.2.3 Significant bleeding diathesis or coagulopathy 3.2.4 History of cerebral aneurysms or\n        cerebral arteriovenous malformations. 3.2.5 Patients with recent (within 12 months)\n        arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular\n        accident (CVA), or clinically significant peripheral artery disease should also be\n        excluded.\n\n        3.2.6 Patients with a history of a gastrointestinal fistula or perforation. 3.2.7 Women who\n        are breast-feeding. 3.2.8 Patients who have undergone major surgery, chemotherapy, or\n        radiotherapy within the last 3 weeks.\n\n        3.2.9 Patients on concurrent anticancer therapy.
interval of at least 3 weeks between end of surgery for recurrent disease and start of protocol therapy for patients who have undergone surgery for recurrent disease
Patient with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1). Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted
SCREENING: Patients with no more than 3 intracranial metastases, which have been definitively treated by surgery or radiation therapy may be eligible for study provided there is no evidence of active disease for at least 2 months
Recovery from effects of recent surgery, radiotherapy, or chemotherapy
Presence of residual disease on final pathology following surgery will be required for immunotherapy; patients with no residual disease at the time of surgery will be removed
Incomplete healing from previous oncologic treatments or other major surgery
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
Subject has history of major surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n* Minor surgery within 1 months of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n* In addition complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Schedule can accommodate both of the following: 2 doses of mirvetuximab soravtansine administered 3 weeks apart and surgery within 9 weeks of last dose of NAC
Patients who may have high burden of disease ie large lesions, who are non-surgical candidates or who refuse surgery
Any BCC that may require Mohs surgery for definitive control
Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
Treatment with surgery or chemotherapy within 21 days prior to study entry
Has had surgery requiring general anesthesia within 4 weeks of starting the study.
Subject needs non-emergency cardiac surgery with cardiopulmonary bypass.
Subject needs emergency surgery.
Use of minimally invasive surgery.
Cardiogenic shock at the time of surgery.
Treatment with Clopidogrel and Ticagrelor within 5 days before surgery, Prasugrel within 7 days before surgery, glycoprotein IIb/IIIa receptor blockers within 24 hours of surgery.
Treatment with new oral anticoagulants (Apixaban, Rivaroxaban, Dabigatran) within 48 hours before surgery.
surgery, radiation, or immunosuppressants within 28 days
Patients scheduled to have routine surgery during the study duration.
Patients with comorbid medical conditions that render them unfit for surgery
Patients with a non-melanomatous, in situ malignancy or disease that is completely resectable with surgery may be considered after discussion with the Medical Monitor
No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
After definitive surgery, e.g.
Less than 28 days elapsed from prior treatment with immunotherapy, radiotherapy, or surgery to the time of randomization.
Prior surgery and/or prior fracture of affected site.
Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
Patients who are not surgical candidates or refuse surgery
Palliative surgery or radiotherapy.
Patients are not allowed to receive prior surgery or chemotherapy for the IHC
Has had surgery requiring general anesthesia within 4 weeks of starting the study
Less than 28 days elapsed from prior radiotherapy, from prior surgery and prior chemotherapy to the time of randomization; less than 42 days elapsed from prior major surgery to the time of randomization
Recovery from the effects of surgery.
Palliative surgery and/or radiation treatment within 30 days prior to date of randomization.
Palliative surgery and/or radiation treatment less than 4 weeks to randomization.
Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
Does the subject have a coagulation profile that would allow for the safe performance of surgery under general anesthesia?
Recent major surgery or trauma, unhealing/open wounds.
Unresectable disease or subject refused surgery.
Patient has histologically confirmed diagnosis of GBM with documented recurrence after first line treatment including radiotherapy and TMZ (SoC), not suitable for curative surgery or re-irradiation.
Histologically confirmed R/M SCCHN of mucosal origin (e.g., oral cavity, oropharynx, hypopharynx, larynx) that is not amenable to further curative local therapy (e.g., surgery, radiation including re-irradiation) (1L R/M)
History of major surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib; major surgery within 6 months of the first dose of cabozantinib if there are complications related to wound healing\r\n* Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications (particularly when associated with delayed or incomplete healing) within 28 days; Note: complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more than 28 days ago
All known lesions were previously treated with surgery or stereotactic surgery (whole-brain radiation is not allowed unless given after definitive treatment with surgery or stereotactic surgery) AND
Incomplete recovery or incomplete healing of wounds from previous surgery
History of eye surgery within 6 months, presence of cataracts or other ocular disorders significantly affecting vision
Placement of an intraperitoneal port at the time of surgery for anticipated use for adjuvant chemotherapy or management of post-operative ascites
Unresectable disease or patient refused surgery.
Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Surgery >= 4 weeks prior to registration
Have undergone surgical, medical and radiation oncology evaluations to confirm:\r\n* Eligible for infusional fluorouracil (5-FU) or capecitabine\r\n* Will not undergo surgery for the study disease\r\n* Able to receive HDR brachytherapy
Patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
GI surgery (particularly when associated with delayed or incomplete healing) within 28 days; Note: complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more than 28 days ago
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* Major surgery (eg, thoracotomy, removal or biopsy of brain metastasis) within 3 months before week 1 day 1; complete wound healing from major surgery must have occurred 1 month before week 1 day 1 and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before week 1 day 1; subjects with clinically relevant ongoing complications from prior surgery are not eligible
Patients must have recovered from the effects of surgery and a minimum of 14 days must have elapsed from the day of surgery to the day of registration; for core or needle biopsy, a minimum of 7 days must have elapsed prior to registration
Patients must have been treated by breast conserving surgery (BCS) or mastectomy
Be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate).
Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.)
Patients must have had 1 attempt at optimal debulking surgery.
Surgery (except minor surgeries,e.g., biopsies) or radiotherapy
At least 30 days since localized surgery, radiotherapy or chemotherapy
Patients who will receive neoadjuvant therapy prior to definitive surgery
Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Treatment of primary tumor within 4 weeks of Day 1 Week 1 with surgery, radiation, chemotherapy or immunotherapy
Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery
All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
Has an elective or planned major surgery to be performed during the course of the trial
for intratumoral cohort, coagulation profile favorable to surgery
Patients should NOT have undergone any prior cancer directed surgery (exploration, debulking, etc), with the exception of a minor procedure such as biopsy or cytology specimen
Surgery within 28 days prior to randomization
Cardiac valvular surgery or open heart surgery
If a patient has had surgery prior to enrolling on study, an enhanced MRI or CT scan should be done within 96 hours prior to surgery or at least 4-6 weeks after surgery
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They are > 2 weeks from surgery\r\n* They have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent tumor is mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, an enhanced CT/MRI should be done no later than 96 hours after surgery or it will need to be done 4-6 weeks post-operatively; if the 96 hour scan is more than 2 weeks from registration, the scan needs to be repeated
Other than surgery, patients may not have therapy for this recurrence (including radiation); supportive care such as steroids or anti-epileptics does not constitute treatment of recurrence
Patient with suspected recurrence of osteosarcoma but who has not had surgery is eligible for enrollment but will not be randomized to receive study medication until deemed fully eligible following surgical removal of all lung nodules.
Patients with advanced or recurrent salivary gland cancer who are not candidates for curative surgery or radiotherapy.
Incomplete healing from previous surgery.
No evidence of macroscopic disease following surgery
Minimal volume, non-disseminated disease, defined by the following:            \r\n* Residual tumor ? 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery\r\n* No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by  both of the following:                \r\n** Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery\r\n** Negative cytological examination of CSF after surgery, but before study enrollment
Major surgery (requiring the use of a general anesthetic) within 4 weeks of study enrollment with the exception of transurethral resection of bladder tumor (TURBT)
Surgery or invasive procedure requiring sutures or staples for closure =< 7 days prior to registration
Patients who have been hospitalized for infection or major surgery (e.g., requiring general anesthesia) within 2 weeks before registration or have not fully recovered from surgery are not eligible; Note: Subjects with surgical procedures conducted under local anesthesia may participate
Negative urinalysis within 30 days prior to date of surgery
All patients must have completed any prior chemotherapy, targeted therapy, radiotherapy (unless palliative doses which must be discussed with study principal investigator), and surgery, >= 28 days before study entry
Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
Any non-cranial surgery within 4 weeks of study registration; must be recovered and fully healed from any prior surgery
Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris
Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery
Surgery must be scheduled no sooner than 10 days after randomization and no more than twelve weeks after randomization
Patient must consent for the appropriate surgery
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
Patient is scheduled to undergo non-small cell lung cancer (NSCLC) resection: video assisted thoracoscopy (VATS) or open thoracotomy for: limited resection, lobectomy, or pneumonectomy; surgery must not be scheduled to take place < 3 weeks after registration
Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
Patients scheduled for surgery at Josie Robertson Surgery Center (JRSC)
Elective surgery anticipated during, pre-, or post-intervention period (e.g., breast reconstruction)
Patients with surgery for osseous metastases are allowed
Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
Chronic sustained-release opioid use for > 2 weeks duration pre operation (op) (in the 30 days prior to surgery)
Prior brain surgery =< 14 days prior to enrollment
Prior surgery in the same site in the breast
Palliative surgery and/or radiation treatment within 30 days prior to date of screening visit.
Is eligible for definitive CRT and not considered for primary surgery based on investigator decision
Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
No planned reconstructive surgery with flap repair during trial and follow-up period
Are planning reconstructive surgery with flap repair during trial and follow-up period
No surgery planned in the next 6 months
PATIENT: Scheduled to undergo surgery
CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery
This study will be conducted in patients and family caregivers who are scheduled to undergo lung or GI cancer surgery treatment
Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery
Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia
Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
PHASE 1 & 2: Identified at least two weeks prior to their scheduled surgery date
Expected primary wound closure performed at the time at surgery
Admitted for surgery lasting > 1 hour and requiring urinary catheter
Have normal urine analysis within 24 hours pre-surgery
Have completed primary treatments (including surgery, radiation, and chemotherapy) 1-5 years prior to recruitment
Planned for bilateral axillary surgery
Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)
History of prior trauma or orthopedic surgery to the cervical vertebral column/spine
Patient is planned to receive interventional procedures (i.e. surgery) that may affect study outcomes
Plastic surgery involvement for oncoplastic reconstruction
If surgery is likely greater than 3 hours
Patients who have a history of previous gastric or duodenal surgery
Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
Subjects that have had prior breast reduction surgery
Will be two weeks post-breast conserving surgery or three weeks post-breast conserving surgery with sentinel lymph node biopsy or four weeks post-mastectomy at the start of participation
Any of the following breast cancer surgery complications; persistent seroma requiring aspiration, wound dehiscence, infection, prolonged drain output, lymphedema
Reconstructive surgery
Other conditions may exclude participants from the study (e.g. intractable nausea/emesis, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)
EXCLUSION - STUDY 1: Undergone surgery in the last 6-8 weeks
No surgery planned in the next 6 months
Patients undergoing penile prosthesis surgery
Prior surgery of the sacrum
Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames:\r\n* Low molecular weight heparin less than 36 hours prior to surgery\r\n* Coumadin less than 5 days prior to surgery\r\n* Plavix and NSAIDs less than 7 days prior to surgery
Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic management less than 24 hours prior to surgery
Patients on Celebrex less than 24 hours prior to surgery
Scheduled for an elective surgery requiring general anesthesia
Scheduled surgery < 4 hrs
Require prone positioning for surgery
Scheduled surgery > 4 hrs
Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery
Previous radiotherapy or palliative surgery to the painful site that is planned for treatment
Most recent INR prior to surgery > 1.4
YBCS: Completed treatment with surgery, radiation and chemotherapy (if applicable)
Prior H&N surgery excluding diagnostic procedures, transoral surgery, or non-radical neck dissection
Bone fracture/surgery of an extremity during the preceding 6 months
Completed primary treatment (surgery, chemotherapy, and/or radiation) at minimum 6-8 weeks before the first group meeting, and maximum 24 months before the first group meeting, which approximates the ‘re-entry’ phase of cancer survivorship.
Patients scheduled for breast surgery
Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment)
Major injuries or surgery (e.g., craniotomy) < 28 days from the start of nintedanib/placebo administration; wound should be healed prior to starting therapy
Received first breast surgery of total or partial mastectomy within the previous 9 months
Report average pain >= 3 during the first nine months after surgery on the Breast Cancer Pain Questionnaire
Undergone laser corrective eye surgery in the past 30 days
Patients undergoing gynecologic surgery via midline vertical laparotomy at University of Wisconsin Hospital and Clinics (UWHC)
Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation
Scheduled for major abdominal oncologic surgery
Patients must have recovered from prior surgery
Have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and Herceptin at least one year previously
An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease; primary therapy is defined as:\r\n* Surgery plus radiation\r\n* Surgery plus chemotherapy\r\n* Surgery plus trastuzumab\r\n* Surgery plus hormone therapy\r\n** Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date; patients who are currently receiving hormone therapy are eligible for enrollment
Treated with chemotherapy and surgery
Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
Recent cholecystectomy, liver resection, or biliary surgery within 12 months.
Acceptable candidate for laparoscopic/robotic gynecology (GYN) surgery as per discretion of the surgeon
PATIENTS: Have completed surgery with no plans for chemotherapy
Survival less than 12 months after surgery (either predicted survival before surgery or actual survival after surgery < 12 months)
Additional surgery at the same time as RC (e.g. nephroureterectomy)
Diagnosis of a childhood cancer or similarly treated disease (involving chemotherapy, radiation, or surgery)
Diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal carcinoma\r\n* Stage II, III, or IV disease with optimal (=< 1 cm residual disease) or suboptimal residual disease\r\n* All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, with appropriate tissue for histologic evaluation\r\n* The minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
Scheduled to undergo surgery for primary or secondary gastric, colorectal, liver, or pancreas cancer
At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
Emergency surgery of any type that does not allow for proper time for protocol review by the patient
Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 months
Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
Serum creatinine < 1.5 measured within 30 days of surgery
Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
Patients who have had mastectomy with reconstructive surgery in one or both breasts
Persistent post-surgical pain at least 3 months after completion of surgery, chemotherapy, and/or radiation
Planned surgery anticipated during the intervention period
The following patient-related situations are allowed: prior surgery, concurrent treatment, homecare, residing in assisted living or a skilled nursing facility, and hospitalization during radiation therapy
Patients need lung isolation for purposed surgery
The patient is undergoing Mohs surgery
The patient is not indicated for Mohs surgery
2 months – 10 years status post surgery, radiation and chemotherapy
History of prior ipsilateral lung interventions including:\r\n* Chest tube placement\r\n* Surgery\r\n* Pleurodesis\r\n* Radiation treatment
Prior therapy:\r\n* Patients who have undergone 1 previous surgery for tibial pseudarthrosis repair will be eligible to enter the study if they have refracture; use of BMP-2 in the prior surgery is permitted, however patients with prior exposure must be screened for antibodies to BMP-2, bovine collagen, and rhBMP-2 neutralizing antibodies; prior use of BMP-2 is allowed but will be recorded as a possible compounding factor\r\n* Patients who have had 2 or more prior surgeries for pseudarthrosis repair are ineligible
Normal ipsilateral fibula without planned fibular osteotomy at time of surgery
Positive antibody titers to BMP-2, bovine collagen, or BMP-2 neutralizing antibodies prior to surgery
A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after 4 complete cycles of treatment
Have had had surgery within four weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
Mastectomy is the surgery performed
Patients who are medically fit for surgery defined as the following
Incomplete healing from wounds from prior surgery
Participants may have had prior breast surgery and/or chemotherapy
Patients who have not undergone surgery in the past 6 months; patients may have had neoadjuvant chemotherapy prior to surgery
Physiologic suitability for major abdominal surgery
All women, undergoing surgery, via a midline laparotomy
Benign or oncologic indications for surgery
Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine
Concomitant panniculectomy or plastic surgery
Adult patients scheduled for thoracic surgery
Use of dexmedetomidine within 28 days prior to day of surgery
Use of long acting opioids pre-operatively 28 days prior to day of surgery
Planned use of an epidural for surgery for post-operative pain relief
Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not a subsequent surgery to manage a postoperative complication) that had occurred =< 7 days prior to registration and that entailed more than a simple hysterectomy
Patients participating in a meditation practice more often than 1 hour per week prior to surgery and/or chemotherapy administration
Surgery for bowel resection (including esophagus to rectum), pancreatic resection, or peritoneal surface malignancy resection
Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration
Planned radiation therapy or surgery to the bone (does not include procedures performed before randomization)
Completed surgery
Incomplete recovery or incomplete healing of wounds from previous surgery, as determined by treating Investigator
Sphincter-preserving surgery and >= 12 months after restoration of bowel continuity
Prior sacral/lower spinal surgery
Those unwilling to participate in the follow-up call 3 months post-surgery
Patient should be at least 4 weeks removed from surgery or radiation in affected arm
Subjects will include women who are being seen at the Women's Health Center by the Gynecological Oncology group at the University of Minnesota (UMMC). These women will be considered for inclusion based on their projected surgery: exploratory laparotomy. Subjects will have to have their surgery at the UMMC within 1 month of their clinic visit. Patients may be undergoing surgery for either known cancer (ovarian or uterine) or high suspicion for malignancy.
scheduled to be discharged the same day of surgery
At least 3 weeks since formal exploratory thoracotomy and patient has recovered from surgery, or 1 week from diagnostic thoracoscopy
Prior extensive pelvic surgery such as low anterior resection, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-risk for complications as deemed by the surgeon
Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)
Planned outpatient surgery
PATIENTS: Scheduled to undergo surgery with lung resection for treatment of primary or secondary neoplasms of the lung
Contraindicated for surgery.
The subject is a current smoker (has smoked within 4 weeks prior to surgery)
> 8 weeks removed from surgery to treat endometrial cancer
Patients must have stage I-III colon or rectal cancer and have undergone definitive therapy; definitive therapy may have included surgery alone, or surgery plus neoadjuvant and/or adjuvant therapy
Scheduled to be discharged the same day of surgery
Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for TIVA (total intravenous anesthesia)
Scheduled to undergo abdominal surgery
Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
Prior open or laparoscopic/robotic bladder or prostate surgery
History of prior surgery for benign prostatic hyperplasia (e.g. transurethral resection of the prostate [TURP] or tissue ablation)
Patients with prior pancreatic surgery or cancers
Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
Patients with any breast surgery or biopsy within 90 days prior to the study
For Arm 1 patients, participation in this study, in the opinion of the treating physicians, will not introduce delays in surgery that would adversely affect the patient
Patients with any breast surgery or biopsy within 90 days prior to the study
Major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
Medical comorbidities making surgery unsafe as determined by the patient's surgeon
Safe for surgery per treating neurosurgeon
A complete blood count (CBC) and chemistry profile (Cohort A2), must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry
Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy)
A complete blood count (CBC) and chemistry profile, must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function and a hemoglobin of 10 or higher
Individuals with prior bariatric surgery procedures
Prior otologic surgery beyond tympanostomy tubes, including, but not limited to, tympanomastoidectomy, cochlear implant, endolymphatic shunt, mastoidectomy, osseous-integrated hearing device
History of gastric surgery
Patients who are treated for a medical condition (such as ulcerative colitis) with chronic steroids during the 2 years prior to planned mastectomy surgery
Patients with a history of gastric bypass surgery
Prior or planned bariatric surgery
Suitable candidate for surgery (meets appropriate performance status, no significant cardiac/renal/hepatic dysfunction)
PILOTS I, II AND III: Less than 3 months post-surgery
Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable)
Positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
Willing to not undergo any other elective surgery procedure with general anesthesia or conscious sedation during the treatment period
Women who are using postmenopausal hormones, and are planning to continue the same regimen through surgery are eligible to participate; if the hormone therapy regimen is cyclical, the following should be recorded regarding the day of baseline core biopsy and day of surgery: the agent, the day of the phase (e.g. day 13 of 14-day estrogen phase etc); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
Inclusion Criteria:\n\n          1. Scheduled to undergo elective colon and/or rectal surgical procedures involving open\n             laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The\n             principal incision must have a length of > 5 cm and < 35 cm in length.  Eligible\n             surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy,\n             ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total\n             abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low\n             anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy\n             takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis,\n             and abdominal perineal resection of the rectum.\n\n          2. Able to give informed consent.\n\n          3. Male or female ?18 years of age.\n\n          4. If female, is non-pregnant (negative pregnancy test result at the\n             Screening/Randomization Visit) and non-lactating.\n\n          5. If female, is either not of childbearing potential (defined as postmenopausal for at\n             least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral\n             oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth\n             control and agrees to continue with this regimen over the study surveillance period:\n\n               -  Oral, implantable, or injectable contraceptives for 3 consecutive months before\n                  the Baseline/Randomization Visit\n\n               -  Intrauterine device\n\n               -  Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or\n                  cream)\n\n               -  Not sexually-active. Agreement to be available for evaluation at the study site\n                  for scheduled visits.\n\n        Exclusion Criteria:\n\n          1. Hypersensitivity to porcine products.\n\n          2. History of known anti-myeloperoxidase autoantibodies (i.e., pANCA), as well as\n             patients with known idiopathic necrotizing glomerulonephritis and certain systemic\n             vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels,\n             Wegener's granulomatosis, and Churg-Strauss Syndrome]).\n\n          3. Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any\n             antimicrobial-embedded suture to close the principal incision or any suture in the\n             surgical field that has not been formally approved by the relevant local national\n             regulatory authority.\n\n          4. Absolute contraindication to general anesthesia.\n\n          5. Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or\n             sutures. (Note: If there can be assurances that the subject will not be exposed to\n             these materials that cause hypersensitivity, alternatives will be allowed.)\n\n          6. History of keloid or hypertrophic scarring within or near an incision from a prior\n             surgery.\n\n          7. Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor\n             wound healing).\n\n          8. ASA score > 3.\n\n          9. Undergoing emergency colorectal surgery such that standard bowel preparation and\n             other standard preoperative precautions and assessments cannot be performed in time\n             before the index-surgery.\n\n         10. The planned index-surgery involves removal or placement of mesh (either synthetic or\n             biological) as part of closure in the principal incision or traversing any part of a\n             pre-existing mesh (either synthetic or biological) in the principal incision.\n\n         11. There are clinical signs of overt infection necessitating systemic antibiotics via\n             oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall,\n             peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.\n\n         12. Preoperative severe neutropenia (total neutrophil count ?500 X 109/L).  (Note:\n             Testing should be performed at the local laboratory.)\n\n         13. Receiving any oral or intravenous antibiotics within 24 hours prior to the\n             index-surgery. (Note: It is permissible to administer conventional oral prophylactic\n             antibiotics as bowel preparation up to the time of the index- surgical procedure, as\n             well as intravenous or intramuscular prophylactic antibiotics just prior to the\n             index-surgery as per the treating surgeon's standard of care.)\n\n         14. Preoperative evaluation that the intra-abdominal process might preclude full closure\n             of the skin incision due to severe or morbid obesity (i.e., any mechanical reason\n             that would prevent/preclude primary intent wound healing) at the principal in
Inclusion Criteria:\n\n          1. Scheduled to undergo elective colon and/or rectal surgical procedures involving open\n             laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The\n             principal incision must have a length of > 5 cm and < 35 cm in length.  Eligible\n             surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy,\n             ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total\n             abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low\n             anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy\n             takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis,\n             and abdominal perineal resection of the rectum.\n\n          2. Able to give informed consent.\n\n          3. Male or female ?18 years of age.\n\n          4. If female, is non-pregnant (negative pregnancy test result at the\n             Screening/Randomization Visit) and non-lactating.\n\n          5. If female, is either not of childbearing potential (defined as postmenopausal for at\n             least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral\n             oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth\n             control and agrees to continue with this regimen over the study surveillance period:\n\n               -  Oral, implantable, or injectable contraceptives for 3 consecutive months before\n                  the Baseline/Randomization Visit\n\n               -  Intrauterine device\n\n               -  Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or\n                  cream)\n\n               -  Not sexually-active. Agreement to be available for evaluation at the study site\n                  for scheduled visits.\n\n        Exclusion Criteria:\n\n          1. Hypersensitivity to porcine products.\n\n          2. History of known anti-myeloperoxidase autoantibodies (i.e., pANCA), as well as\n             patients with known idiopathic necrotizing glomerulonephritis and certain systemic\n             vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels,\n             Wegener's granulomatosis, and Churg-Strauss Syndrome]).\n\n          3. Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any\n             antimicrobial-embedded suture to close the principal incision or any suture in the\n             surgical field that has not been formally approved by the relevant local national\n             regulatory authority.\n\n          4. Absolute contraindication to general anesthesia.\n\n          5. Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or\n             sutures. (Note: If there can be assurances that the subject will not be exposed to\n             these materials that cause hypersensitivity, alternatives will be allowed.)\n\n          6. History of keloid or hypertrophic scarring within or near an incision from a prior\n             surgery.\n\n          7. Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor\n             wound healing).\n\n          8. ASA score > 3.\n\n          9. Undergoing emergency colorectal surgery such that standard bowel preparation and\n             other standard preoperative precautions and assessments cannot be performed in time\n             before the index-surgery.\n\n         10. The planned index-surgery involves removal or placement of mesh (either synthetic or\n             biological) as part of closure in the principal incision or traversing any part of a\n             pre-existing mesh (either synthetic or biological) in the principal incision.\n\n         11. There are clinical signs of overt infection necessitating systemic antibiotics via\n             oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall,\n             peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.\n\n         12. Preoperative severe neutropenia (total neutrophil count ?500 X 109/L).  (Note:\n             Testing should be performed at the local laboratory.)\n\n         13. Receiving any oral or intravenous antibiotics within 24 hours prior to the\n             index-surgery. (Note: It is permissible to administer conventional oral prophylactic\n             antibiotics as bowel preparation up to the time of the index- surgical procedure, as\n             well as intravenous or intramuscular prophylactic antibiotics just prior to the\n             index-surgery as per the treating surgeon's standard of care.)\n\n         14. Preoperative evaluation that the intra-abdominal process might preclude full closure\n             of the skin incision due to severe or morbid obesity (i.e., any mechanical reason\n             that would prevent/preclude primary intent wound healing) at the principal in
Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered
Women who are willing to have a Mirena IUD inserted at least 10 days prior to risk-reducing surgery or who already have the Mirena in place
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena IUD
History of esophageal or gastric surgery
Participants with fundoplication within the past year, bariatric surgery or any other major upper gastrointestinal (GI) surgery; fundoplication more than one year ago will not be grounds for exclusion; cholecystectomy will not be grounds for exclusion
Individuals with a history of bariatric surgery or planned bariatric surgery within 2 years
Planned reconstructive surgery with flap repair during study period
Subjects who have undergone bariatric surgery are not eligible
Scheduled to have surgery for bladder cancer during the study
Patients must be undergoing surgery that is clinically indicated as determined by their care providers
Breast-conserving surgery with surgical excision of all gross disease with negative surgical margins (with the exception of a positive margin at skin and/or fascia where no more breast tissue can be removed) or mastectomy surgery with no gross residual disease
Minimum 3-week interval from last chemotherapy administration and last breast surgery to radiation
Maximum 8-week interval from last chemotherapy administration or last breast surgery (whichever is more recent) to radiation
Patients on blood thinners (aspirin or Coumadin) will be asked to stop medications 7 days prior to surgery; in the case of Coumadin, patients are switched to Lovenox 7 days prior to surgery and this is stopped the day before surgery; following surgery aspirin or Coumadin are recommenced 48 hours post operation (postop)
Patients who have received surgery alone or radiotherapy alone as definitive local therapy
Subject has an active ocular condition that in the opinion of the investigator may alter visual acuity during the course of the study (i.e., ocular inflammatory disease etc.) or a history or anticipation of major ocular surgery (including cataract extraction, intraocular surgery, etc.) during the study.
Medical comorbidities making surgery unsafe as determined by the patient’s surgeon
Patients who’ve received a therapeutic course of antibiotics within 15 days prior to thoracic surgery
History of surgery involving the luminal gastrointestinal (GI) tract, including bariatric surgery; exception: prior appendectomy is not an exclusion criterion
Surgery/biopsy planned as part of clinical care that is anticipated to yield sufficient material to meet the minimum requirements for profiling; OR
Definitive surgery being performed at MSKCC within 0-60 days of completing NAC
Surgery (mastectomy or BCT) planned within 60 days of the MRI
Individuals can have a prior history of cancer; these individuals must be in stable remission and at least 6 months out from the completion of surgery/radiation therapy/chemotherapy; individual cases can be reviewed with the institutional principal investigator
Individuals can have a prior history of cancer; these individuals must be in stable remission and at least 6 months out from the completion of surgery/ radiation therapy/ chemotherapy; individual cases can be reviewed with the institutional principal investigator
The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
Who are scheduled to undergo endoscopic or thoracic surgery surgery
Subjects must be enrolled before starting chemoradiation, either pre -or post-surgery
Be scheduled for surgery to remove the adnexal mass
Scheduled to undergo surgery at Memorial Sloan-Kettering (MSK)
Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
Eligible for breast conserving surgery, lumpectomy and radiation
Previous surgery for DCIS or invasive cancer
No or equivocal ER, PR or HER2 testing performed prior to surgery if biopsy indicates invasive cancer
No or equivocal ER testing performed prior to surgery if biopsy indicates ductal carcinoma in situ
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
Patients who are cleared for surgery
Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
History of active anal disease requiring surgery
Prior thoracic surgery on the same side of the lung as the SPN.
Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
Previous thoracic surgery
Patients who are unable to tolerate surgery
Operated for debulking, decompression or separation surgery
Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes
Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
History of ER+ pathology (ER+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required)
Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study
No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
Plasma creatinine in excess of 180 umol/L within 30 days prior to surgery
Indications for stress testing is either: \r\n* As part of a pre-operative evaluation prior to a planned cancer related surgery that is considered to be at least of intermediate risk (Intra-peritoneal, intra-thoracic, head and neck surgery, orthopedic or prostate surgery) OR \r\n* As an evaluation in the cardiology clinic for symptoms described in a cardiology consult as typical angina, or of significant suspicion for coronary disease or symptoms described as likely of a cardiac/coronary etiology
Prior anti-incontinence surgery
Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites
Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option
Subjects expecting to undergo surgery between the imaging sessions; subjects may undergo surgery at any time before the first, or after the last imaging session; this exclusion only applies to each study visit (3 day scanning session), and does not apply to the time (at least 3 weeks) between each study visit
Will undergo surgery or chemo-radiation treatment
Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals – Chapel Hill location
Medical conditions precluding radiation therapy or curative intent surgery
Patients with other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery
Patient not a candidate for surgery (neck dissection) because of an underlying medical condition
Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor
Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
Patients with a solid lung lesion 1.5-5cm identified on chest CT (obtained within previous 3 months) that are surgical candidates with a high probability of cancer (> 65%) will be referred for surgical evaluation; if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up > 75% of the lesion and measure at 1.5-5cm; if the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study; all sites will use the same online calculator to document probability of malignancy
Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
Participants may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy
Patients with newly diagnosed glioblastoma multiforme (GBM) and one of the following options:\r\n* Eligible for surgery after the last research scan\r\n* Significant residual disease after initial surgery\r\n** The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease\r\n* Treatment (non-surgical) naive
Prior treatment of the prostate gland for malignant conditions (surgery, cryotherapy, radiotherapy, or photodynamic therapy)
Scheduled to undergo primary debulking surgery
Patient desire to undergo breast surgery
Patient desire to undergo breast conserving surgery
Mohs surgery located on a site that may not be convenient to confocal imaging
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
Prior resection surgery is allowable.
Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel
Ileostomy or hepatic resection during current cytoreductive surgery
Patients must be deemed to be eligible candidates for either surgery or stereotactic radiation
Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies
Candidate for surgery
Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Has had previous surgery or radiation to node basins that would be involved in the ILM procedure
Receiving care in the Breast Surgery Department at Columbia
Patients not receiving breast surgery care from the Department of Breast Surgery at Columbia Medical Center
No recent chemotherapy or surgery, as defined as in the last 6 months
scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts)
Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics
Patients with Barrett’s esophagus scheduled for esophageal surgery
Patients with gastroesophageal reflux disease (GERD), but without Barrett’s esophagus scheduled for esophageal surgery
Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection)
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
Contraindications for surgery
Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options
Be contraindicated for surgery
Patients must be considered an appropriate candidate for surgery by a qualified surgeon
Patients with a history of prior thyroid/parathyroid surgery will be excluded from the study.
Attempted maximal cytoreductive surgery; patients will still be eligible whether optimal or suboptimally debulked at the completion of the surgery
Patients who had prior major gastrointestinal surgery removing part of gastrointestinal tract and/or gall bladder.
recovered from any prior surgery
Patient with prior rectal surgery or anal stricture requiring surgical intervention prior to biopsy.
Being treated with definitive chemoradiotherapy or surgery
Scheduled to undergo surgery that will result in the creation of an ileostomy
Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
Patients who have already undergone any thyroid surgery will be excluded
Patient opted for robotic (da Vinci robot) or laparoscopic surgery
Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
Undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study.
Who are scheduled to undergo laparotomy for the debulking surgery OR
Previous exposure to OTL38 2. Known FR-negative ovarian cancer 3. Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
Timing of surgery: Must be anticipated to take place at least 1 hour after BLZ-100 administration
Patients who require surgery sooner than 28 days from enrollment
Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
Subjects undergoing a second surgery because they had positive margins in a previous surgery.
Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ?3 months.
Who are scheduled to undergo laparotomy for the debulking surgery OR
Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
Planned surgical approach via laparoscopy or robotic surgery
Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.
History of prior surgery on the oropharynx, neck, esophagus, or stomach
Major surgery (eg, laparotomy, thoracotomy or joint replacement) within 3 weeks prior to randomization or elective surgery scheduled to be performed during the study.
Women who have declined or otherwise not received preceding surgery
Women with positive margins after primary surgery
No prior curative attempts for this cancer, (i.e., surgery, radiation and/or other)