Trial Information

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

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

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
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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