Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible
Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina\r\n* Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible
Patients who have gross residual disease or distant metastatic disease
Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings
Status post gross total resection with curative intent
Any evidence of hematemesis, melena, hematochezia, ? grade 2 hemoptysis, or gross hematuria
History of gross hemoptysis.
Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
The only surgical consideration is biopsy. Subjects who had gross total resection, partial resection and/or debulking are excluded.
Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
Participant has symptoms of gross hematuria or gross hemoptysis
Patients must have received no previous therapy for the tumor with the exception of corticosteroids and surgery; patients with a gross total resection will not be eligible
Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
Have evidence of active clinically significant bleed (e.g., gastrointestinal bleed, hemoptysis, or gross hematuria) at screening
Uncontrolled cystitis, significant bladder pain or spasms, or gross hematuria that in the opinion of the treating investigator, should preclude study entry
Patients who have undergone a gross total resection for recurrence will be eligible, and MLA will be directed at treating a peritumoral margin of 0.5-1 cm surrounding the resection cavity to disrupt the blood brain barrier (BBB) and potentially increase access of MK-3475 to the peritumoral infiltrating glioma cells
On-going gross hematuria associated with clots
Gross total excision of both the primary and nodal disease
The patient must be a candidate for surgical debulking (either subtotal or gross total resection); biopsy-only candidates will not be eligible
Patients must have undergone gross total surgical resection within 42 days prior to registration and beginning of therapy under the clinical trial. Note: Patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection.
Presence of metastatic disease or gross orbital involvement
No evidence of gross hematuria
Gross (visible) hematuria
Gross disease within the breast must be unifocal; (patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less)
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 with gross residual tumor after surgical resection
COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging
Evidence of gross duodenal invasion, gastric outlet obstruction
Current evidence of hematemesis, melena or gross hematuria
Presence of metastatic disease or gross (residual) orbital involvement
Absence of residual or disseminated disease as defined by the following criteria:\r\n* Minimal residual disease as determined by post-operative imaging preferably performed within 48 hours of resection (and at most 28 days post-surgery), i.e. gross total resection or residual disease of < 1.5 cm^2 on post-operative imaging
Patient’s will have no evidence of gross vascular invasion
Patients who had craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted.
Prior craniotomy and gross total or sub-total resection of tumor at this recurrence
Gross total or partial tumor resection is not possible or not planned
Patients with gross total resection of the primary tumor prior to enrollment are not eligible; patients who have experienced tumor recurrence after gross total tumor resection are not eligible
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx squamous cell carcinoma (SCC) within 63 days prior to registration; note: patients may have a biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but demonstrate rapid gross recurrence or are determined to have gross persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; Note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
Candidate for gross total or subtotal resection
Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease; in other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed
Previous radiosurgery to any currently progressive gross metastatic disease
Total (aggregate) gross tumor volume > 500 cm^3 (500 cc’s or 0.5 liters)
Active untreated gross hematuria for any cause
Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS
Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible\r\n* The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
Resected tumor: No evidence of gross tumor at the surgical resection margin noted in the final surgery report. No evidence of gross residual adenopathy
Patients who have had gross total excision of the primary tumor.
gross extension of tumor to the skull base;
Patients who had craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted
The tumor must be unifocal, confined to the supratentorial compartment and have undergone a gross total or near gross total resection; this will increase the likelihood that the patient will not require corticosteroids or develop pseudoprogression
History of gross hemoptysis within 2 months of study entry.
Patients must have had all gross disease resected (R0 or R1 resection)
Not undergoing surgical resection or for whom gross total resection is not possible
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
Achieved a gross total or sub-total resection at time of surgery
Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
The patient must have undergone surgical resection (gross total, subtotal, or biopsy) of the spinal lesion(s) no more than 16 weeks prior to SRS treatment
Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report
Participants with gross hematuria are not eligible; patients with microscopic hematuria are eligible
Participants with gross hematuria are ineligible
Patients with more than 2 (i.e., 3 or greater) uncontrolled or untreated extracranial sites of gross disease
Gross extension of tumor into the lumen of the duodenum
Subjects must have undergone primary gross total resection (no re-resected patients are allowed) with fulfillment of at least 1 of the following histologic criteria for high-risk disease:
Participants may have had a gross total resection, sub-total resection or biopsy\r\nonly
Patients with tumors adjacent to a vertebral body are eligible, unless there is demonstrable bone invasion, as long as all gross disease can be covered to the total radiation dose while respecting spinal cord tolerance
Patients who have undergone gross total resection and have no detectable residual disease are eligible
Gross total resection as determined by the intraoperative observations of the neurosurgeon of record and confirmed by postoperative MR imaging; gross total resection is defined as residual tumor or imaging abnormality (not definitive for residual tumor) whose size is < 1 cm^2 on postoperative computed tomography (CT) or MR images
Histologic diagnosis of nodular desmoplastic medulloblastoma with less than gross total resection, but with no evidence of metastasis
Prior cancer treatment for this cancer, including gross total tumor excision
Participants with a history of gross hemoptysis within 2 months prior to study treatment
Pulmonary hemorrhage or gross hemoptysis within 12 months
Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment
Gross total resection followed by conventional chemoradiation therapy without progression of disease.
Patients with gross disease involving only the posterior elements
Patients with both pedicles involved with gross disease at the level of potential cement augmentation
Symptoms of gross hematuria or gross hemoptysis.
Patients with clinical evidence of gross disease
Gross nodal or metastatic disease at presentation (>= N1, M1)
Patients with gross tumor involvement of the oral cavity or oral mucosa
No gross disease visible on imaging at the start of radiotherapy
Definitive/gross total lesion resection
No gross disease visible on imaging at the start of radiotherapy
Subtotal, gross total or biopsy patients will be eligible
Gross tumor volume (GTV) or resection cavity must be visible on CT such that it can be delineated as a target for radiotherapy