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:

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  2. 1/9/15 1/9/15 - Martin Dugas
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Pre-Randomization Colon Cancer Stage III N0147 NCT00079274

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  1. StudyEvent: N0147: NCI Cooperative Group Pre-Randomization Form
    1. No Instruction available.
Header module
Reporting Period
Protocol Administration
Patient Demographics/pre-treatment Characteristics
Patient Gender
Patient Race
Patient Ethnicity
Method of Payment
Is patient age 70 and over
Kras Results Contact
Kras Results Contact
Histologically documented adenocarcinoma of the colon
At least one pathologically confirmed positive lymph node identified
There must be no evidence of residual involved lymph node disease
ECOG performance status (PS) 0, 1, or 2
18 Years and older
Must be willing to provide blood and tissue samples for eligibility and research purposes, as described in Sections 14.0 and 17.0
Tumor tissue will be made available to NCCTG for centralized KRAS testing prior to registration/randomization
A pre-randomization pathology review is required. The site has reviewed and understands the process listed in Section 17.0 and must account for sufficient time to complete pre-randomization and registration/randomization steps.
Any of the following: Pregnant women, Nursing women, Men or women of childbearing potential who are unwilling to employ adequate contraception
Evidence of residual involved lymph node diseases
Distant metastatic disease at the time of registration/randomization
Prior chemotherapy or radiation therapy for treatment of this malignancy
Prior therapy with agent(s) directed against EGFR
Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies
Previous or concurrent malignancy
Any of the following conditions (Uncontrolled high blood pressure, Unstable angina, Symptomatic congestive heart failure, Myocardial infarction less than 6 months prior to randomization, NYHA class III or IV, Symp pulmonary fibrosis or intersitial pneumonitis, Active uncontrolled bacterial, viral, Systemic fungal infection)
Other medical condition which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Clinically significant peripheral neuropathy at the time of randomization
Concurrent use of other anti-cancer therapy including chemotherapy agents, target agents, or biological agents
Known allergy to other platinum compounds
History of gastrointestinal bleeding that has not been appropriately addressed based on assessment of the enrolling physician
Pre-randomization Check
Request Letter for Immunohistochemistry Test Results has been given to the patient
Consent form signed and dated
Authorization for use and disclosure of protected health information signed and dated
Patient has agreed by signature of consent form to allow tissue and blood samples to be used for correlative science studies associated with this study
Patient will automatically be registered to the translational research component of this study at the time of pre-randomization.
Blood draw kit availability checked
The Following Will Also Be Recorded:
Patient has given permission to store blood and paraffin-embedded tissue for future research of colorectal cancer
Patient has given permission to store blood and paraffin-embedded tissue for future research to prevent, or treat other health problems
Patient has given NCCTG permission to give their blood and paraffin-embedded tissue to outside researchers
The Following Will Also Be Recorded:
Protocol Design
Assigned Treatment

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