STEP 2 REGISTRATION
SECOND REGISTRATION (STEP 2)
STEP 0: REGISTRATION (Optional)
Patients with a primary colon or rectal cancer resection who are potentially eligible for S0820 may be pre-registered at Step 0; patients registered to Step 0 will appear on an institutional patient tracking report; patients registered to Step 0 are not registered to the S0820 protocol; to participate in S0820, patients must be registered to Step 1 after patient is consented and evaluation of eligibility; patients registered to S0820 at Step 0 continuing to Step 1 registration must use the same Southwest Oncology Group (SWOG) patient identification (ID) for registration to S0820 Step 1
STEP 1: REGISTRATION
STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy
STEP II: Any adverse event related to step 1 therapy must have resolved to grade 2 or less
STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II)
STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to Step II)
STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to randomization to Step II)
STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization to Step II)
STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II)
STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28 days prior to randomization to Step II)
Registration Step 1  Induction/Re-Induction:
Registration Step 2  Post-Remission Therapy:
PRIOR TO STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
STEP 2: RANDOMIZATION
STEP 1
Patients must have discontinued radiation therapy prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications
PRIOR TO STEP 1 REGISTRATION:
PRIOR TO STEP 2 REGISTRATION:
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Leukocytes >= 3,000/mcL
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Absolute neutrophil count >= 1,500/mcL
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Platelets >= 100,000/mcL
PRIOR TO STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
PRE-REGISTRATION (STEP 0)
RANDOMIZATION (STEP 1)
Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
STEP 1 (REGISTRATION)
STEP 2 (REGISTRATION)
STEP 1 REGISTRATION
STEP 2 REGISTRATION
PRIOR TO STEP 1 REGISTRATION:
PRIOR TO STEP 2 REGISTRATION:
PRIOR TO STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
PRIOR TO STEP ONE RANDOMIZATION:
PRIOR TO STEP TWO RANDOMIZATION:
STEP 1 REGISTRATION
PRIOR TO STEP 2 REGISTRATION
Financial clearance for proton therapy treatment prior step 2 registration