Colon Cancer Clinical Trial
Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.
Full Description
OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.
OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 42 Locations for this study
Scottsdale Arizona, 85259, United States
San Francisco California, 94115, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60637, United States
Peoria Illinois, 61602, United States
Urbana Illinois, 61801, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 10309, United States
Iowa City Iowa, 52242, United States
Sioux City Iowa, 51101, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Columbia Missouri, 65203, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Buffalo New York, 14263, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58122, United States
Grand Forks North Dakota, 58201, United States
Toledo Ohio, 43623, United States
Danville Pennsylvania, 17822, United States
Providence Rhode Island, 02903, United States
Rapid City South Dakota, 57709, United States
Sioux Falls South Dakota, 57105, United States
Memphis Tennessee, 38163, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23298, United States
Regina Saskatchewan, S4S 6, Canada
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.