Must not have received any prior radiation to any sites of measurable disease
Received radiotherapy to metastatic sites of disease <2 weeks prior to Day 1.
At least two sites of biopsy for those cases where mammographic extent of calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling pathology eligibility criteria
Prior radiotherapy must in general have been completed >= 2 weeks prior to randomization and patients must have recovered from the toxicity of the radiation\r\n* NOTE: Patients may receive concurrent radiation therapy to painful sites of bony disease or areas of impending fracture as long as sites of measurable or non-measurable disease outside the radiation therapy port are available to follow
Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization
ELIGIBLE SITES:\r\n* Extremities: upper (including shoulder) and lower (including hip)\r\n* Trunk: body wall
Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to stereotactic body radiation therapy (SBRT) or resection (at least one disease site must be amenable to radiation); some examples of what constitutes specific radiation treatment sites defining distinct metastatic disease sites are as follows: a) A lesion in each adrenal gland represents 2 of 3 sites of metastatic disease allowed to be treated on protocol; b) Similarly to NRG study RTOG 0631, disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment; and c) Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment.
All known disease amenable to metastasis-directed therapy with either SBRT or resection\r\n* NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered\r\n* NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites\r\n* NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
Patients with bronchiectasis in the region of the intended implantation sites
PARTICIPANTS FROM ST. JUDE AND COLLABORATING SITES PARTICIPATING IN THERAPEUTIC AND BIOLOGICAL OBJECTIVES:
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN THERAPEUTIC AND BIOLOGICAL OBJECTIVES:
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN BIOLOGICAL OBJECTIVES ONLY:
Patients may not receive or have received any radiation therapy at the biopsy sites.
Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision\r\n* Distant sites of disease are allowed\r\n* Prior radiation to the chest wall is not required
Oligometastatic state is defined by =< 3 active sites of disease, including the primary site
Among patients with multiple sites of metastatic disease, the other sites that will not be treated on this protocol have either been previously treated or are planned for local treatment
Patients are stage IV (M1) or recurrent with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease \r\n* NOTE: number of metastatic sites based on most recent imaging studies in order to determine number of oligometastatic sites; for example, if patient initially had 10 sites of metastatic disease, was treated with chemotherapy resulting in complete response of 5 lesions and stable disease of 5 lesions, and no new lesions based on repeat imaging, the patient would be eligible for treatment on protocol
Ineligible disease sites include the following\r\n* Lymphoma\r\n* Leukemia\r\n* Multiple myeloma\r\n* Primary central nervous system (CNS)\r\n* Peritoneal carcinomatosis \r\n* Colon cancer with liver-only metastatic disease that is treatable with surgical resection
Other\r\n* Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis. \r\n* Metastatic disease sites must be treatable with stereotactic radiosurgery (at discretion of treating physician); patients with oligometastatic sites not amenable to SRS treatment, either through size or locations, are ineligible for this trial
Metastatic disease sites must be treatable with SRS (at discretion of treating physician)
Ineligible disease sites include the following\r\n* Lymphoma\r\n* Leukemia\r\n* Multiple myeloma\r\n* Primary CNS\r\n* Peritoneal carcinomatosis \r\n* Colon cancer with resectable liver-only lesions
Examples of patients ineligible for trial\r\n* T1N1M1 NSCLC with 1 CNS lesion, 1 bone lesion, 1 adrenal lesion and a cervical lymph node (4 sites of metastatic disease)\r\n* T2N1M1 Gastric cancer with 6 liver lesions (more than 5 sites of metastatic disease)
For United Kingdom sites:
For United Kingdom sites:
Patient may not have disease limited to a single skin or bone site, with the following exceptions:\r\n* Central nervous system (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are “special sites” (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus ARE eligible for the study\r\n* Functionally critical lesions: a single lesion not described above which may cause “functionally critical anatomic abnormality” wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity; these patients may be enrolled with approval of the principal investigator (PI) and documentation of the rationale justifying systemic therapy
Has at least 2 identified sites of metastatic disease by imaging.
Evidence of neuroblastoma outside osteomedullary sites (any neuroblastoma outside osteomedullary sites must have been removed prior to trial entry)
Liver metastases with no other metastatic sites
Subjects must give informed consent according to the rules and regulations of the individual participating sites.
1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
Tumour sites amenable to repeated biopsies.
No more than three progressive sites of disease, with at least one of the disease sites to be deemed suitable for treatment with MRI-guided, online adaptive SBRT to the non-liver abdomen as per radiation oncology evaluation
Measurable disease in at least 2 non-radiated sites
Any number of metastatic disease is allowed in the pilot phase of the trial\r\n* For the phase II, metastatic patients will be allowed only if all sites of metastasis has been treated either surgically or radio-surgically; (if limited sites of metastasis are present, all of which can be resected during the nephrectomy, then the patient can be eligible)
We will allow XRT prior to study entry to other sites, with no washout period, allowed prior to study entry as long as at least one measurable sites of disease is kept unirradiated
No active infection: patients should be afebrile; if present, pulmonary infiltrates or other sites of infection must be improving on antibiotics; patients should not require oxygen; study chair will be the arbiter of this criterion
At least two sites of measurable disease as defined by RECIST 1.1; one of which must be amenable to treatment with SAR and accessible for optional pre- and post- treatment biopsy; if a pulmonary nodule is being considered for SAR it must range in size from 1-5 cm
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
Progressive disease or sites of new metastasis after definitive therapy for oligometastatic disease
Participants who have received prior radiation therapy to anatomical sites other than brain or skeleton
Patients with another active malignancy; asymptomatic sites of disease are not considered active; treated or untreated sites of disease may be considered inactive if they are stable for at least 2 months and are not expected to require therapy for 4 months
Patients must have at least ONE of the following sites of disease:
Local-regional treatment sites must be able to be encompassed within a reasonable radiation therapy treatment volume
Patients with any number of metastatic site are allowed to enroll; however, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist
Patient must be eligible for SABR to one or more extra cranial sites
Radiographic evidence of metastatic disease documented with bone scan or computed tomography (CT) scan\r\n* Patients with any number of metastatic site are allowed to enroll; however, only up to six sites will be selected for stereotactic body radiation therapy (SBRT) treatment, at the discretion of the treating radiation oncologist
Presence of lesions that are amenable for injections as determined by interventional radiology\r\n* NOTE: Nodal or extranodal sites must be palpable and easily accessible; sites such as mediastinum, retroperitoneum, within solid organs, spinal sites, central nervous system (CNS) sites, etc., are NOT allowed
IA involving sites other than lungs and sinuses
Patients must have at least two sites of disease amenable to biopsy
Radiation fields to include at least two mucositis sites at risk (buccal mucosa, floor of mouth, ventral and lateral tongue, soft palate) in which both sites receive a minimum cumulative dose of 55 Gy
Measurable metastatic disease (by RECIST version [v] 1.1) in the peritoneal cavity or retroperitoneal lymph nodes; disease outside of the peritoneal cavity is allowed as long as metastatic sites are also present within the peritoneum/retroperitoneum
Eligible for neutron radiation treatment to 1-3 sites of metastatic disease (lesions do not have to be symptomatic)
Patients must have measurable disease in at least 2 non-radiated sites as defined by RECIST v1.1; all sites must be evaluated within 4 weeks prior to beginning therapy
Patients must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:\r\n* Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment**\r\n* Pathologic confirmation of metastases from at least one of the resected sites\r\n** For patients with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery\r\n* Note: If surgery related changes such as atelectasis are seen on the post-operative computed tomography (CT) scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected; patients with positive microscopic margins will be eligible to enroll
Patients with CNS disease or other sites of extra-pulmonary metastases at the time of most recent episode of disease recurrence preceding enrollment
For the phase II portion of the study, subjects must have disease that is evaluable for response; subjects who have had radiation to all sites of disease are not eligible unless there is imaging evidence of active tumor, ie: increased blood volume
Patients must have had no prior radiotherapy to tumor-involved sites
PHASE II: Patients must have measurable disease outside of the primary tumor (pancreas) by RECIST 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to randomization
PHASE II: Patients must have measurable disease based on RECIST 1.1; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to registration
Patients must have measurable advanced disease, that is not resectable by surgery; all sites must be assessed within 4 weeks prior to randomization
Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization; any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration; the most recent procedure may be nephrectomy for a renal primary tumor
Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease)
Sites must seek additional patient consent for the future use of specimens
Archival tumor samples must be obtained from primary and/or metastatic sites
All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease
Pain must be from one painful metastatic lesion involving the bone that is amenable to cryoablation with CT (additional less painful metastatic sites may be present)
Metastatic disease, unresectable disease involving one or more sites including liver, lung, lymph nodes and peritoneum, with each nodule measuring =< 3 cm OR no more than two sites of disease (two nodules) > 4.5 cm
Tumor sites that can be accessed for repeat biopsies
Patients with metastatic sites that requires chemotherapy and/or non-hormonal targeted therapy
Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with T4b cancer:
Phase I run in: biopsy proven RMHNSCC with the following primary sites: nasopharynx, paranasal sinus, nasal cavity, skin/cutaneous sites; patients with unknown head and neck primary sites will be enrolled; patients with recurrent or metastatic squamous cell carcinomas of the head and neck (regardless of primary site) who are either unwilling to receive or have contraindications (deemed by treating physician) to standard systemic chemotherapy will also be eligible; patients with biopsy proven RMSGC be eligible as well
Patients with concomitant primaries of the bladder/urethra are allowed, as long as these sites are surgically resected and non-invasive cancers (< cT1N0)
Measurable disease; Note: previously irradiated sites can be included if there is documented disease progression in that site
The subjects must have at least four BCCs in non-cosmetically sensitive sites
Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT
Patients may have additional non-painful or minimally painful osseous metastases (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the BPI compared to the site[s] treated)
Subjects must have ? 1 measurable disease sites
1-3 sites of metastatic disease able to be targeted by SABR
Radiotherapy to >= 3 sites at the same time within 1 week prior to the first day of treatment
Last radiotherapy treatment >= 4 weeks prior to starting treatment with this protocol and there must be sites of measurable disease that did not receive radiation
Patients with metastatic sites that requires chemotherapy
CRPC with metastatic disease with at least one site of metastatic disease must be amenable to needle biopsy; soft tissue biopsy sites include: lymph node or visceral metastases; bone sites include lumbar vertebrae, pelvic bones and long bones; excluded sites are thoracic, cervical vertebrae, skull and rib lesions; biopsy site will be selected with guidance of interventional radiologist determining best site to optimize balance of obtaining useful tissue for analysis and minimizing risk
Primary sites other than oral cavity
Tumor sites eligible for inclusion on this protocol include thorax, abdomen, and pelvis
Patients must not have experienced distant disease progression since the start of systemic therapy, as evidenced by clinical and radiographic documentation of disease status before treatment and within 6 weeks prior to randomization, including:\r\n* No new sites of disease\r\n* No enlargement of existing sites by 20% or more in longest diameter\r\n* No symptomatic deterioration\r\n* Imaging at step 2 should preferably be the same as at step 1 (baseline); it must address all previous sites of disease and all clinical signs and symptoms; if all step 1 imaging tests cannot be repeated, the reason should be documented (e.g. declined by insurance); step 2 imaging must evaluate all known sites of disease and address all signs/symptoms present at step 2
Maximum of number of lesions per patient will be 5 total for all disease sites
OTHER METASTATIC SITES:
Oropharyngeal sites of tumor include tonsil, soft palate, base of tongue, lateral and posterior pharyngeal wall; laryngeal sites of tumor include the supraglottic, glottis and subglottic larynx; nasopharyngeal sites include the posterior nasopharyngeal wall, right and left fossa of Rosenmuller; the hypopharyngeal sites of tumor include the post-cricoid area, posterior pharyngeal wall and the pyriform sinuses
Breast cancer with metastasis to skeletal sites only
All patients to be included in this study must be presented to the principal investigator using Horizon Live Web-conferencing through the Cure4Kids website; eligibility and target CNS sites will be determined, as well as non-target sites
Mutation load determined by FoundationOne of >= 13 mutations/MB tested on archival tumor sample; the mutation load metric will be displayed on the FoundationOne report for all participating sites or may be obtained from Foundation Medicine from older reports using the Insights Portal, which will be available to all participating sites, or by emailing Foundation Medicine
Must have ?1 measurable disease sites as defined by standard Lugano classification.
Prior radiotherapy to disease sites is allowed with certain protocol-defined restrictions.
Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated as per ipilimumab/Yervoy® package insert (applicable for US sites) or product information (applicable for Australia site).
Any contraindications for ipilimumab/Yervoy® as per package insert(applicable for US sites) or product information (applicable for Australia site).
Pain must be from one or two painful metastatic sites in the bone (additional less painful metastatic sites may be present)\r\n* Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, magnetic resonance imaging (MRI), or ultrasound (US) imaging\r\n* Metastatic tumors must be amenable to cryoablation with CT or MRI
At least 2 sites of disease\r\n* One for palpable for biopsy and treatment (if > 2 sites are present, the biopsy site can be different from the treatment site); if there is no palpable disease, ultrasound may be used for guidance and administration of SD-101\r\n* One measurable radiographically or by skin assessment
Availability of a representative tumor specimen. Patients enrolled in Arm 3 of Phase II must have disease sites amenable to biopsy unless prior agreement between Novartis and the Investigator.
Systemic sites of disease need to be stable on systemic therapy based on the most recent (within 12 weeks) staging scans
Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (=< 5 discrete lesions of disease irrespective of location, inclusive of the primary lesion):\r\n* All sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology\r\n* All intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion\r\n* Each brain metastasis is included as a distinct lesion\r\n* Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib
Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT
Patients must have measurable disease as defined by immune-related complete response (irRC) (Wolchok, 2009); all sites must be evaluated within 4 weeks prior to beginning therapy
X-rays and/or scans to assess all disease sites are to be completed within 30 days prior to day -2 (or the next business day if falls on a weekend or holiday)
May be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites.
Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study
Sites must seek additional patient consent for the future use of specimens
PATIENT: Receiving primary cancer care at one of the participating sites
Patients with multiple osseous sites are eligible; however should not treat more than 3 separate radiation treatment fields concurrently
Treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least 1 year of follow up after date of diagnosis
Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)
Primary cancer care at one of the three participating sites
Clinician inclusion criteria:\r\n* Oncology staff nurses who undergo training to deploy CONNECT, oncologists, and practice managers at participating sites will be eligible to participate
Radiographic evidence* of bone metastases within 8 weeks of study for non-weight bearing sites and 4 weeks for weight bearing sites; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites and not all identifiable lesions will require treatment unless they are painful lesions\r\n* This should be one of the following:  plain film, bone scan, positron emission tomography (PET) scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI)
Eligible treatment sites are:\r\n*Weight bearing sites\r\n** Pelvis (excluding pubis) \r\n** Femur\r\n** Sacrum and/or sacroiliac joints\r\n** Tibia\r\n** Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies\r\n** Lumbosacral spine\r\n*Non-weight bearing sites\r\n** Up to 3 consecutive ribs\r\n** Humerus\r\n** Fibula\r\n** Radius +/- ulna\r\n** Clavicle\r\n** Sternum\r\n** Scapula\r\n** Pubis\r\nIf multiple sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur or tibia
Patients will be eligible for treatment of multiple synchronous osseous sites only if those sites can be included in no more than three treatment sites; for patients with painful metastases that are contiguous but do not fit into the definition of a site listed above, those patients will still be eligible but will be considered to have two treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be eligible but would be considered as two treatment sites since more than five consecutive vertebral bodies would be treated; these lesions could be treated with one field, even though the treatment is coded as two sites
Unhealed or infected surgical sites in the irradiation area
Prior radiotherapy to the region of the study cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemotolerance)
Local skin infections at or near the acupuncture sites or are under treatment for active systemic infection
Patients must give informed consent according to the rules and regulations of the individual participating sites
Presence of extensive skeletal metastases defined as more than five (5) sites of bony disease, or any symptomatic site of disease in the spine, hip, or femur; Note that, patients with more than five bony sites may be deemed eligible at the discretion of the attending oncologist
Local skin infections at or near the acupuncture sites or active systemic infection
Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
Patients participating through PK sites, must be offered the option to submit blood specimens for population pharmacokinetic analysis
prior radiation to the sites to be treated
Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites
Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)
Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
No metastatic sites >= 20 mm
Patient has esophageal narrowing limiting access to the intended sites of ablation
Dana Farber Cancer Institute (DFCI) oncologists are excluded from this study; this includes DFCI satellite sites, non-DFCI Dana Farber (DF)/Harvard Cancer Center (HCC) sites, and other non- DF/HCC sites that are under the DFCI Institutional Review Board (IRB)
recruited through primary care sites aligned with study
Patients with bronchiectasis in the lobe of the intended implantation sites.
At least 2 distinct measurable metastatic sites, which are 1 cm or larger