Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00031863|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: rofecoxib Procedure: adjuvant therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy|
|Study Start Date :||February 2001|
|Actual Study Completion Date :||September 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031863
|Radcliffe Infirmary NHS Trust|
|Oxford, England, United Kingdom, OX2 6HE|
|Study Chair:||David J. Kerr, MD, FRCP, DSc||Oxford University Hospitals NHS Trust|