[c09aa8]: / clusters / ordered9kclusters / clust_24.txt

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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)
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)
No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration
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 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
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
Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator
Subject has received surgery within the last four weeks.
Major surgery other than diagnostic surgery, within 4 weeks prior to the first dose of test drug, minor surgery including diagnostic surgery within 2 weeks (14 days) excluding central IV port placements and needle aspirate/core biopsies. Radio frequency ablation or transcatheter arterial chemoembolization within 6 weeks prior to the first dose of test drug.
Patients who cannot undergo 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)
Surgery to the lesion in question is allowed if size criteria outlined above are met
Patient has had surgery within seven days prior to the date of informed consent.
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
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.
Patients must have surgery planned to remove the desmoid tumor and either:
the desmoid tumor has already recurred after a prior surgery or
Planned procedure or surgery during the study
Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 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
Completed pre-operative chemo radiotherapy followed by 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
Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
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
Not eligible for surgery
At least 4 weeks post-surgery prior to first dosing of study agent
Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 8 weeks to the date of surgery
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
Platelets > 80,000 compatible for surgery
Elective indication for nephron sparing surgery
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.
Surgery unable to be performed between 1 – 3 days after radiosurgery
Substantial recovery from surgery resection
Deemed ineligible for surgery by the enrolling physician
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.
Prior biliary bypass surgery
Pituitary surgery within six months
Laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
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)
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
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
Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement
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
Treatment must be initiated >= 14 days and < 6 weeks from surgery
Medical indication or subject desire to undergo BC surgery prior to completing at least 14 days of treatment with ODM-201.
Planned to get local surgery
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
Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study
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
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
Any stage, considered candidates for surgery and scheduled for surgery either by robotic or by standard surgical technique
The patient’s refusal to proceed with curative breast surgery has to be documented by the surgeon’s and medical oncologist’s note
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.
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
Inability to safely delay surgery by 8 weeks as per surgeon’s discretion
No prior definitive surgery for HNSCC
Prior breast surgery which interrupts communication of the ductal systems with the nipple
Evidence of residual disease after surgery and SoC adjuvant therapies
Patients who have had secondary debulking 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
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
Prior surgery for this cancer
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
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
Therapy must begin =< 5 weeks after surgery or biopsy
Before administering liposomal doxorubicin, patients must wait 4-6 weeks after surgery
Patients found to have non-gynecologic, uterine, or breast primary at surgery
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
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
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
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
Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion is allowed
Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Patients who have had non-biopsy surgery in the last 10 days
If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery.
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
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.
ELIGIBILITY CRITERIA FOR REGISTRATION: subjects undergoing primary debulking surgery must have stage III or IV disease and have undergone surgery to include, at a minimum, removal of the uterus, ovaries and fallopian tubes; these patients may be optimally debulked (less than 1 cm residual disease) but must have grossly visible macroscopic residual disease OR be suboptimally debulked
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
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)
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
The attending surgeon considers the mass to be amendable to robotic assisted 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)
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
Patients must be deemed to be in adequate health to undergo major surgery (pancreaticoduodenectomy)
Minor surgery within 7 days of first dose of STA-9090
History of gastric or small bowel surgery.
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.
Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive diagnostic surgery (Day 0)
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)
The subject must have received maximal debulking surgery and undergo radiotherapy concomitant with temozolomide (45-70 gray [Gy])
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 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
Patients who require WBRT or surgery at the time of enrollment
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
Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction
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
Not curable by 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).
Previous TransOral Robotic Surgery (TORS) to the oropharynx
If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery
Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study
Treatment directed against the resected melanoma that is administrated after the surgery
Breast surgery planned
Patients with a history of prior pituitary surgery must be at least 30 days post-surgery to be eligible for inclusion in this study.
Have significant loss of gastrointestinal organs, except for appendix, due to surgery
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.
Pregnant at time of surgery
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;
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
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
Prior therapy or surgery (3 to 10 weeks depending type)
At least 4 weeks must have lapsed since major surgery (e.g., laparotomy, laparoscopy, thoracotomy, video assisted thoracoscopy) prior to study treatment initiation
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)
No history of bariatric 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
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
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
Eligible to undergo excisional surgery such as pleurectomy/decortication (P/DC) or any other mesothelioma surgery.
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
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
For those participants who do not require radiation, registration must be within 84 days of surgery.
Margin negative 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
Patient must be registered/randomized to Step 2 within a maximum of 7 weeks following surgery
Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
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).
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
Patients may have received Gliadel during surgery
Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
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)
Surgery within 2 weeks prior to dosing
Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
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.)
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
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
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
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
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
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.
Patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible
Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers
Patients must begin treatment as outlined in the protocol within 31 days of definitive surgery
Estimated blood loss > 2 liters during surgery
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
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)
Interval of at least 3 weeks after biopsy or open surgery and able to begin study treatment.
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
Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor
SURGERY:
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
Any BCC that may require Mohs surgery for definitive control
Subjects who have participated in another investigational study within 30 days prior to 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 with a non-melanomatous, in situ malignancy or disease that is completely resectable with surgery may be considered after discussion with the Medical Monitor
After definitive surgery, e.g.
Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
Recent major surgery or trauma, unhealing/open wounds.
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
Placement of an intraperitoneal port at the time of surgery for anticipated use for adjuvant chemotherapy or management of post-operative ascites
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
Has at least one or more intraoperative visible air leak >= 2 mm following the lung resection surgery
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
No evidence of macroscopic disease following surgery
Surgery or invasive procedure requiring sutures or staples for closure =< 7 days prior to registration
Negative urinalysis within 30 days prior to date of 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
Anticipating surgery, history of hypothyroidism, profound anemia (hemoglobin level of < 10 g/dL =< 28 days prior to registration), or clinical depression per physician discretion
Patient must consent for the appropriate surgery
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
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
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 must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery
Admitted for surgery lasting > 1 hour and requiring urinary catheter
Plastic surgery involvement for oncoplastic reconstruction
If surgery is likely greater than 3 hours
Subjects that have had prior breast reduction surgery
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)
No surgery planned in the next 6 months
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
Require prone positioning for surgery
Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery
Most recent INR prior to surgery > 1.4
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
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
Additional surgery at the same time as RC (e.g. nephroureterectomy)
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
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
Patients who have had mastectomy with reconstructive surgery in one or both breasts
Planned surgery anticipated during the intervention period
The patient is not indicated for Mohs surgery
Positive antibody titers to BMP-2, bovine collagen, or BMP-2 neutralizing antibodies prior to surgery
Mastectomy is the surgery performed
Physiologic suitability for major abdominal surgery
Benign or oncologic indications for surgery
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
Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration
Sphincter-preserving surgery and >= 12 months after restoration of bowel continuity
Prior sacral/lower spinal surgery
No blood?thinning medications, including anti?inflammatory medications, herbs and supplements for at least 1 week prior to surgery
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.
if they are currently using or planning on using other complementary alternative medicine (CAM) therapies prior to or after 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
Contraindicated for surgery.
Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days 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
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
Patients with any breast surgery or biopsy within 90 days prior to the study
Patients with any breast surgery or biopsy within 90 days prior to the study
Safe for surgery per treating neurosurgeon
Individuals with prior bariatric surgery procedures
History of gastric surgery
Patients with a history of gastric bypass surgery
Prior or planned bariatric surgery
PILOTS I, II AND III: Less than 3 months post-surgery
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
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
Maximum 8-week interval from last chemotherapy administration or last breast surgery (whichever is more recent) to radiation
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
Definitive surgery being performed at MSKCC within 0-60 days of completing NAC
Surgery (mastectomy or BCT) planned within 60 days of the MRI
Subjects must be enrolled before starting chemoradiation, either pre -or post-surgery
Patients who are cleared for surgery
Operated for debulking, decompression or separation surgery
An MRI performed within 72 hours after surgery is needed
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
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
Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
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
Patient desire to undergo breast surgery
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
Prior resection surgery is allowable.
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
Electronic version of pre-surgery MRI must be available for co-registration purposes
Be contraindicated for surgery
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.
Being treated with definitive chemoradiotherapy or surgery
Patient opted for robotic (da Vinci robot) or laparoscopic surgery
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
Planned surgical approach via laparoscopy or robotic surgery
Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.
Women who have declined or otherwise not received preceding surgery