STEP 2 REGISTRATION
10000.0
SECOND REGISTRATION (STEP 2)
155.0
STEP 0: REGISTRATION (Optional)
491.0
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
491.0
STEP 1: REGISTRATION
491.0
STEP II: Step 2 registration must be within 6 weeks of completing step 1 therapy
1080.0
Registration Step 1 � Induction/Re-Induction:
44.0
Registration Step 2 � Post-Remission Therapy:
44.0
Registration Step 3 � Maintenance: Patients must have adequate marrow function as evidenced by ANC >= 750/mcl within 28 days prior to registration
44.0
PRIOR TO STEP 1 REGISTRATION
606.0
PRIOR TO STEP 2 REGISTRATION
606.0
Documentation of steroid doses within 28 days prior to step 2 registration
606.0
STEP 1
300.0
PRIOR TO STEP 1 REGISTRATION:
510.0
PRIOR TO STEP 2 REGISTRATION:
510.0
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Leukocytes >= 3,000/mcL
6452.0
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Absolute neutrophil count >= 1,500/mcL
6452.0
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Platelets >= 100,000/mcL
6452.0
PRIOR TO STEP 1 REGISTRATION
302.0
PRIOR TO STEP 2 REGISTRATION
302.0
PRE-REGISTRATION (STEP 0)
345.0
STEP 1 (REGISTRATION)
56.0
STEP 2 (REGISTRATION)
56.0
Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
612.0
STEP 1 REGISTRATION
1000.0
STEP 2 REGISTRATION
1000.0
PRIOR TO STEP 1 REGISTRATION:
148.0
PRIOR TO STEP 2 REGISTRATION:
148.0
PRIOR TO STEP 1 REGISTRATION
282.0
PRIOR TO STEP 2 REGISTRATION
282.0
STEP 1 REGISTRATION
120.0
PRIOR TO STEP 2 REGISTRATION
120.0
Financial clearance for proton therapy treatment prior step 2 registration
120.0
PRE-REGISTRATION INCLUSION CRITERIA:
360.0
REGISTRATION INCLUSION CRITERIA:
360.0
PRE-REGISTRATION
509.0
PRE-REGISTRATION ELIGIBILITY CRITERIA:
195.0
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
110.0
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
302.0
PRE-REGISTRATION ELIGIBILITY CRITERIA:
130.0
PRE-REGISTRATION ELIGIBILITY CRITERIA
30.0
ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:
747.0
Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria
368.0
Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met
74.0
ELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDY
180.0
INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
2918.0
POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
2918.0
Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
97.0
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
97.0
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Platelet count >= 50 x 10^9/L
97.0
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN)
97.0
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
97.0
INDUCTION ELIGIBILITY CRITERIA-STEP 1
509.0
POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)
509.0
Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
509.0
ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
562.0
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization
562.0
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
562.0
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24 weeks from surgery
562.0
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100,000 mm^3
562.0
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =< 2.5 x ULN
562.0
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =< 2.5 x ULN
562.0
STUDY SITE ELIGIBILITY:
222.0
REGISTRATION ELIGIBILITY CRITERIA:
195.0
REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
110.0
ELIGIBILITY CRITERIA (STEP 1)
302.0
REGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIA
130.0
ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):
766.0
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
766.0
REGISTRATION ELIGIBILITY CRITERIA
30.0
INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
689.0
INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)
689.0
Patients must have met eligibility criteria for the screening step
689.0
Site must verify that there is no known change in the step 1 eligibility since initial registration
1000.0
REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
324.0
RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)
324.0