At a glance
ClinicalIndex Comparison Record- ✓Histologically documented adenocarcinoma of the colon with gross inferior margin above the peritoneal reflection (rectal cancers excluded).
- ✓Completely resected primary tumor with R0 resection confirmed; positive proximal or distal margins are exclusions.
- ✓Node-positive disease (N1 or N2 per AJCC v7), including at least one pathologically confirmed positive lymph node or N1C (tumor deposits in subserosa, mesentery, or non-peritonealized pericolic/perirectal tissues).
- ✓No evidence of residual involved lymph node disease or metastatic disease at registration.
- ✕Rectal cancer (tumor with inferior margin at or below peritoneal reflection); synchronous colon and rectal primaries.
- ✕Resected stage IV disease; patients with synchronous colon cancers where staging is based on the more advanced N stage are eligible.
- ✕Positive proximal margin or distal margin after resection.
- ✕Regular NSAID use >2 times per week or aspirin >325 mg ≥3 times per week; low-dose aspirin ≤100 mg/day permitted.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
In Brief
A Phase 3 clinical trial evaluating celecoxib, 5-fluorouracil, and 3 other interventions for Colorectal Cancer. Completed, enrolled 2,527 participants across 842 sites in 3 countries.
Detailed Summary
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.
Study Details
Timeline
Interventions
Patients receive celecoxib 400 mg administered by mouth, once daily.
Patients receive 400 mg/m\^2 intravenous bolus then 2400 mg/m\^2 continuous intravenous infusion over 46-48 hours.
Patients receive placebo administered by mouth, once daily.
Patients receive 85 mg/m\^2 intravenous over two hours.
Patients receive 400 mg/m\^2 intravenous over two hours.