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| Sponsor: | Cancer Research Campaign Clinical Trials Centre |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031863 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: rofecoxib Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy |
| Study Start Date: | February 2001 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 7,000 patients (1,750 per treatment arm) will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
Must have received potentially curative therapy within the past 12 weeks, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United Kingdom | |
| Radcliffe Infirmary NHS Trust | |
| Oxford, England, United Kingdom, OX2 6HE | |
| Study Chair: | David J. Kerr, MD, FRCP, DSc | Oxford University Hospitals NHS Trust |
More Information
| ClinicalTrials.gov Identifier: | NCT00031863 History of Changes |
| Other Study ID Numbers: | CDR0000069235, CRC-TU-VICTOR, EU-20054, CRC-TU-COX2, ISRCTN98278138, NCCTG-N004B |
| Study First Received: | March 8, 2002 |
| Last Updated: | November 11, 2010 |
| Health Authority: | United States: Federal Government |
|
stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic Rofecoxib Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |