[c09aa8]: / clusters / clusters342final / clust_249.txt

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Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institutions upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done
Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study (or within 31 days prior to day 1 of chemo post-surgery for those patients having started chemotherapy prior to first step registration); patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead
Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or dissection) within 90 days prior to registration * Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.5 cm
Clinical stage: T2N1, T3N0, T3N1* N2 disease is to be estimated as four or more lymph nodes that are >= 10 mm* Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest/abdomen/pelvis and either a pelvic magnetic resonance imaging (MRI) or an ultrasound (endorectal ultrasound [ERUS]); if a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis
Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging
Assessable disease with a positive bone scan and/or measurable disease on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) of the abdomen and pelvis
Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration
Computerized tomography (CT) urogram or magnetic resonance imaging (MRI) urogram; if urogram protocol not available or contrast allergy/poor renal function preclude such imaging, then noncontrast CT or MRI of the abdomen/pelvis within 45 days of study entry will suffice
Part C: Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
Patients with screening ALT/AST or ALP above institutional upper limit of normal should have liver ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) at any time point between diagnosis of current breast cancer and randomization; screening bone scan is required if ALP and/or corrected calcium level are above the institutional upper limit; (note positron emission tomography [PET]/CT scan may be used as an alternative imaging technique)
The following imaging workup to document metastases within 45 days prior to study registration: * Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT
Patients must have staging scans with abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) scan and CT scan or x-ray of the chest within 56 days prior to registration; if alkaline phosphatase is above the treating institutions upper limit of normal (ULN), presence of suspicious bone pain, or if other clinical suspicion, a whole body bone scan is required within 56 days prior to registration
Patients with evidence of extramedullary disease at diagnosis will have computed tomography (CT) scan or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis to obtain baseline values within 28 days prior to registration
Solid tumor patients must be off corticosteroids prior to registration; if GBM patient is receiving corticosteroids, patient must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline magnetic resonance imaging (MRI) or computed tomography (CT); if steroids are added or the steroids dose is increased between the date of the screening MRI or CT and the start of treatment, a new baseline MRI or CT is required
Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigators opinion, could compromise the patients safety, or put the study at undue risk; patients with suspicious radiologic evidence of aspergillosis infection (i.e., chest computed tomography [CT] and/or brain magnetic resonance imaging [MRI]) will not be eligible unless confirmatory laboratory testing of beta-D glucan and aspergillus antigen are negative
No evidence of any lymph node spread or distant metastases as determined by positron emission tomography (PET) computed tomography (CT) imaging within 16 weeks of enrollment; alternatively, for those without PET CT capability, a magnetic resonance imaging (MRI) or CT of the abdomen and pelvis and a chest x-ray confirming no evidence of metastatic disease is acceptable
Patients must have no evidence of metastatic disease or clinically enlarged lymph nodes on computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis and CT chest obtained within 28 days of registration (a negative biopsy is required for lymph nodes >= 1 cm in size to confirm lack of involvement); patients with lymph nodes >= 1 cm in whom a biopsy is deemed not feasible are not eligible; patients with elevated alkaline phosphatase or suspicious bone pain should also undergo baseline bone scans to evaluate for bone metastasis
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements above are met
Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained within 4 weeks prior to randomization and must be acquired by multiphasic computed tomography (CT) or contrast magnetic resonance imaging (MRI)* NOTE: positron emission tomography (PET)-CT scans are allowed provided the CT portion of the exam is equivalent to a diagnostic CT scan and includes both oral and IV contrast
The patient must have the following assessments done =< 8 weeks prior to randomization:* Examination by a head and neck surgeon* Chest x-ray (or chest computed tomography [CT] scan or CT/positron emission tomography [PET] of the chest or magnetic resonance imaging [MRI]) to rule out distant metastatic disease
No evidence of metastases other than regional lymphadenopathy as assessed by imaging of the chest, abdomen and pelvis with CT of the chest and CT or MRI of the abdomen; regional lymph nodes, per 7th edition American Joint Committee on Cancer (AJCC) staging manual (2010) for kidney cancer, include the following positions: renal hilar, precaval, paracaval, retrocaval, interaortocaval, paraaortic, preaortic, and retroaortic
Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease
Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration* Chest X-ray, 2 view (or chest CT, or positron emission tomography [PET]/CT) is required only if clinically indicated or recommended by National Comprehensive Cancer Network (NCCN) guidelines* Bone scans (with x-rays of abnormal areas) are required only if indicated or recommended by NCCN guidelines* Abdominal imaging is required only if clinically indicated or recommended by NCCN guidelines
The tumor must be clinically determined to be locally advanced stage II or stage III rectal cancer, and must also meet any ONE of the following criteria:* Distal location (as defined by measurement on magnetic resonance imaging [MRI], transrectal ultrasound [ERUS]/pelvic computed tomography [CT] [with IV contrast] scan or palpable on digital rectal examination [DRE]): cT3-4 =< 5 cm from the anal verge, any N* Bulky: any cT4 or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan* High risk for metastatic disease with 4 or more regional lymph nodes (cN2); clinical nodal or cN status for eligibility includes the total number of nodes (N2 = 4 or more) in the mesorectal and superior rectal stations measuring >= 1.0 cm in any axis on cross sectional or endoscopic imaging; Note: nodes must measure 1.0 cm or greater to be considered positive for this eligibility requirement* Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)** Note: clinical stage of the primary tumor and nodes may be determined locally by rectal endoscopic ultrasound or pelvic MRI (MRI is strongly preferred); CT scan with IV contrast is acceptable provided there is evidence of T4 and/or N2 disease
Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 28 days prior to randomization; Note: Distant clinical staging to exclude patients with overt metastatic disease is determined by:* Chest: CT scan (preferred); chest x-ray posterioranterior (PA) and lateral (acceptable); or positron emission tomography (PET) scan (acceptable)* Abdomen: CT scan with IV contrast (preferred); or MRI (acceptable)* Pelvis: MRI (preferred) or CT scan with IV contrast (acceptable)** (It is recommended that the same imaging tests that are performed before randomization be used at follow-up time points; Note: CT scans of the abdomen and pelvis must be performed with IV contrast)
Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration
Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms
Patients must not have had urothelial carcinoma in the prostate or upper urinary tract within the previous 24 months, or muscle invasive urothelial carcinoma of the bladder at any time; patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis to rule out upper tract malignancy and intra-abdominal metastases within 90 days prior to registration
Patients must have localized disease with a primary tumor >= 5 cm by magnetic resonance imaging (MRI) or computed tomography (CT) scan
No clinical evidence of regional lymph node metastasis* Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within 120 days prior to step 1 registration* Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1 cm in the short axis