Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer Source Form: NCI FormBuilder:

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
  4. 9/24/15 9/24/15 - Martin Dugas
  5. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Registration/Randomization Eligibility Checklist Colon Cancer N0147 NCT00079274

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  1. StudyEvent: N0147 Registration/Randomization Eligibility Checklist
    1. No Instruction available.
Header module
Assigned Treatment Arm
Required Characteristics
Randomization must occur =< 56 days post surgery
KRAS wild-type status determined by central testing
Laboratory values obtained <= 28 days prior to randomization
Hgb >=9 g/dL
Absolute neutrophil count >= LLN
Platelet count >= 100,000/mcL
Serum Creatinine <=1.5 x ULN
Total bilirubin <= 1.5 x ULN
Is patient a woman of childbearing potential
Negative serum pregnancy test
Registration/randomization Check
KRAS mutant status determined by central testing, or KRAS status not evaluable
Must collect translational research blood sample for Section 14.2 following pre-randomization, but prior to registration/randomization
Study drug availability checked
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU member physician
Treatment cannot begin prior to randomization and must begin <= 14 days after randomization
Pretreatment tests must be completed within the guidelines specified on the test schedule
All required baseline symptoms must be documented and graded in the patient's medical record
Patient Instructions for Prevention and Treating Diarrhea and Patient and Physician Fact Sheet have been given to the patient; treating physician has discussed their contents with the patient
Stratification Factors At The Time Of Randomization
Positive lymph node involvement
Clinical T Stage
Descriptive Factors At The Time Of Registration/randomization
Baseline stools reported
Protocol Design

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