Status:
COMPLETED
Celebrex With Preoperative Chemoradiation - Rectal Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Ontario Cancer Research Network
Princess Margaret Hospital, Canada
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatmen...
Eligibility Criteria
Inclusion
- patients with resectable or potentially resectable adenocarcinoma of the rectum
- clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)
- age greater than 18 years, ECOG performance status \< 2 (appendix, section 13.1)
- biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
Exclusion
- Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy
- History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)
- Pregnancy
- Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU
- Significant comorbid illness
- History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
- Use of aspirin, other NSAID or coxib in the two weeks prior to study entry
- Neutrophil count \<1.5x109/L, platelet count \<100x109/L, serum bilirubin \>1.25xULN (upper limit of normal), AST/ALT \>3xULN, serum creatinine \>1.25xULN
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00188565
Start Date
March 1 2004
End Date
March 1 2009
Last Update
August 13 2010
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9