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.
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.
Study Type
INTERVENTIONAL
Purpose
PREVENTION
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Antrim Hospital
Antrim, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, United Kingdom
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Bristol, England, United Kingdom
Frenchay Hospital
Bristol, England, United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom
Derby City General Hospital
Derby, England, United Kingdom
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Dudley, England, United Kingdom
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Leicester, England, United Kingdom
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...and 22 more locations