Colorectal Cancer
Conditions
Keywords
colon cancer, rectal cancer
Brief summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously. PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.
Detailed description
OBJECTIVES: * Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive oral aspirin and oral folic acid daily. * Arm II: Patients receive oral aspirin and oral placebo daily. * Arm III: Patients receive oral placebo and oral folic acid daily. * Arm IV: Patients receive 2 oral placebos daily. In all arms, treatment continues for 3 years in the absence of unacceptable toxicity. After completion of the 3-year intervention, all patients undergo a surveillance colonoscopy. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.
Interventions
DIETARY_SUPPLEMENTfolic acid
DRUGacetylsalicylic acid
Sponsors
Queen's Medical Center
Study design
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal adenoma removed within the past 6 months * Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal * OR * Any size with a history of prior colorectal adenoma removal(s) * Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery * Removal must be considered complete with follow-up to be done within 6 months * No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy) PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * No active bleeding disorders Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No unstable heart conditions Pulmonary: * No unstable asthma Other: * Not pregnant and no potential to become pregnant within the next 3 years * No unstable diabetes * No active upper gastrointestinal ulceration * No known aspirin intolerance or sensitivity * No other serious medical conditions that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No other concurrent folic acid * No concurrent anticoagulants * No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)
Countries
United Kingdom
Outcome results
None listed