ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:
Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria
Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met
ELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDY
INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
PHASE I PORTION ELIGIBILITY CRITERIA
Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients randomized to Arm 1 may opt to switch to the 3-drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria below
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status 0-2
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Platelet count >= 50 x 10^9/L
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN)
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
INDUCTION ELIGIBILITY CRITERIA-STEP 1
POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)
Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): No specific timeframe between registration and randomization needs to be observed, as long as:* Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date* Randomization occurs no more than 24 weeks from surgery date
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24 weeks from surgery
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =< 2.5 x ULN
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =< 2.5 x ULN
STUDY SITE ELIGIBILITY:
PRE-REGISTRATION ELIGIBILITY CRITERIA:
REGISTRATION ELIGIBILITY CRITERIA:
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
ELIGIBILITY CRITERIA (STEP 1)
PRE-REGISTRATION ELIGIBILITY CRITERIA:
REGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIA
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
PRE-REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA
Patients must have met eligibility criteria for the screening step
Site must verify that there is no known change in the step 1 eligibility since initial registration
REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)
Eligibility criteria to participate in group 1 of the pilot study of the AYA-Hears instrument Note: participants in group 1 will not receive protocol-directed therapy