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Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer Clinical research trials and Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer clinical trial. Participants frequently get the best healthcare available for their Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer  Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
For Condition: stage 3 colon cancer,stage 2 rectal cancer,stage 2 colon cancer,stage 3 rectal cancer
Status: Recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: 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: Randomizedphase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal carcinoma - Stage II (T3-4, N0, M0) or stage III (any T, N1-2, M0) disease - Completely resected primary tumor without gross or microscopic evidence of residual disease - Must have received potentially curative therapy within the past 12 weeks, including any of the following: - Surgery alone - Surgery plus radiotherapy and/or chemotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 1.5 times ULN Renal: - Creatinine clearance greater than 30 mL/min Cardiovascular: - No severe congestive heart failure Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No active peptic ulcer or gastrointestinal bleeding within the past year - No inflammatory bowel disease - No known sensitivity to rofecoxib - No prior adverse reaction to non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., asthma, acute rhinitis, nasal polyps, angioneurotic edema, or urticaria) - No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics Other: - No concurrent long-term NSAIDs except low-dose aspirin (no more than 80 mg/day) for cardio-prophylaxis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidKerr, Study Chair, Radcliffe Infirmary NHS Trust
Radcliffe Infirmary NHS Trust *Recruiting*
Oxford, England, OX2 6HE
United Kingdom
Recruiting David Kerr 44-1865-224-482
Additional Information:
Study ID Numbers: CDR0000069235; ISRCTN-98278138,CRC-TU-COX2,CRC-TU-VICTOR,EU-20054
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031863
Other Stage 2 Colon Cancer Studies:
1. PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
2. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
3. Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
4. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
5. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Related Studies:
Other stage 2 colon cancer Clinical Trials
Other England Clinical Trials
Other Oxford Clinical Trials
Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
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