Trials / Completed
CompletedNCT00031863
Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Cancer Research Campaign Clinical Trials Centre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective in treating colorectal cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer.
Detailed description
OBJECTIVES: * Compare the overall survival of patients with previously resected stage II or III colorectal cancer treated with rofecoxib vs placebo administered for at least 2 years vs 5 years. * Compare the relapse-free survival of patients treated with these regimens. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to participating center, site of disease (colon vs rectum), disease stage (II vs III), age, adjuvant chemotherapy (yes vs no), and type of chemotherapy regimen (1 vs 2 vs 3 vs 4 vs 5). Within 3 months of surgical resection alone or completion of adjuvant radiotherapy and/or chemotherapy after surgical resection, patients are randomized to one of four treatment arms. * Arm I: Patients receive oral rofecoxib once daily for 2 years. * Arm II: Patients receive oral rofecoxib once daily for 5 years. * Arm III: Patients receive oral placebo once daily for 2 years. * Arm IV: Patients receive oral placebo once daily for 5 years. Treatment continues in all arms in the absence of disease recurrence or unacceptable toxicity. PROJECTED ACCRUAL: A total of 7,000 patients (1,750 per treatment arm) will be accrued for this study within 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rofecoxib | |
| PROCEDURE | adjuvant therapy |
Timeline
- Start date
- 2001-02-01
- Completion
- 2007-09-01
- First posted
- 2003-01-27
- Last updated
- 2013-08-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00031863. Inclusion in this directory is not an endorsement.