Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Colorectal Cancer
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically documented colorectal cancer that has been curatively resected, including: Dukes' A/B1 (T1-2, N0, M0) Dukes' B2/C (T3, N0, M0 and any T, N1, M0) disease-free more than 5 years post-resection Colonoscopy to the cecum (or small bowel anastomosis) with removal of all polyps required within 4 months of entry Preparation must be adequate to visualize mucosa and discern the presence of no further polyps No familial polyposis (more than 100 polyps at time of resection) No history of inflammatory bowel disease including ulcerative colitis or Crohn's disease PATIENT CHARACTERISTICS: Age: 30 to under 75 Performance status: Physician's assessment of good general health required Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class III/IV status No history of angina No history of MI No history of stroke or TIAs No peripheral vascular disease No bleeding diathesis including hemorrhagic stroke No prophylactic aspirin for cardiovascular disease Other: No documented peptic ulcer disease within past 15 years No aspirin sensitivity including: Aspirin-induced asthma Bronchial hyper-reactivity Urticaria Angioedema No requirement for sodium warfarin or other anticoagulant No frequent (greater than 36 times/year) NSAID use within the past 5 years No recurrent arthritis or other musculoskeletal problems No narcotic or alcohol dependency (unless there has been at least a 6-month period of abstinence) No prior or concurrent malignancy within 5 years (including metastases) except nonmelanomatous skin cancer No pregnant or nursing women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: No concurrent enrollment in a colon cancer treatment trial or other chemoprevention trial Biologic therapy: At least 6 months since immunosuppressive therapy (i.e., azathioprine, methotrexate, cyclosporine) Chemotherapy: Prior chemotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent chemotherapy Endocrine therapy: Prior non-immunosuppressive steroid treatment allowed Radiotherapy: Prior radiotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent radiotherapy Surgery: Curative resection required
Sites / Locations
- CCOP - Scottsdale Oncology Program
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Mount Sinai Medical Center
- University of Chicago Cancer Research Center
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- University of Iowa Hospitals and Clinics
- Siouxland Hematology-Oncology
- CCOP - Ochsner
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Massachusetts General Hospital Cancer Center
- University of Massachusetts Memorial Medical Center
- CCOP - Ann Arbor Regional
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- CentraCare Clinic
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- CCOP - Missouri Valley Cancer Consortium
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- New York Presbyterian Hospital - Cornell Campus
- State University of New York - Upstate Medical University
- Lineberger Comprehensive Cancer Center, UNC
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Quain & Ramstad Clinic, P.C.
- CCOP - Merit Care Hospital
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinical and Medical Center
- Rhode Island Hospital
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- University of Tennessee, Memphis Cancer Center
- Vermont Cancer Center
- MBCCOP - Massey Cancer Center
- Saskatchewan Cancer Agency
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Aspirin
Placebo
325 mg/day PO