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Therapeutic Areas: Oncology | Gastroenterology | Family Medicine
Disease Category: Colon Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

CTSU CALGB C80702 Phase III Randomized Study of Adjuvant FOLFOX Chemotherapy Comprising Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Celecoxib in Patients With Resected Stage III Colon Cancer

Purpose

To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib.

Patient Inclusion Criteria:

  • Age >18 years
  • Histologically confirmed adenocarcinoma of the colon
  • Stage III disease
  • The gross inferior (caudal) margin of the primary tumor must lie above the peritoneal reflection
  • No rectal cancer
  • Synchronous colon cancers allowed
  • No synchronous colon and rectal primary tumors
  • Completely resected tumor
  • Patients with adherent to adjacent structures, en bloc Ro resected tumor, must have it documented in the operative report
  • Near or positive radial margin are not exclusions as long as en bloc resection was performed
  • Positive proximal margin or distal margin is an exclusion
  • Patients with resected stage IV disease are not eligible
  • Node-positive disease (N1 or N2) as designated in AJCC version 7
  • Either at least one pathologically confirmed positive lymph node or N1c (defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases)

Patient Exclusion Criteria:

  • No evidence of residual involved lymph node disease or metastatic disease
  • To Learn more
    Phase

    3

    Gender

    Both Male and Female

    Age

    18 and up

    Overall Status

    Recruiting

    Facility Type

    N/A

    Contact

    Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
    Sherman Health
    1425 North Randall Road
    Elgin, IL 60123
    Phone: 224-783-2907
    Fax: 224-783-3071

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    Research Center Information: Sherman Health

    If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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    CW ID: 183104

    Date Last Changed: July 17, 2013


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