UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
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.
Interventional
Primary Purpose: Prevention
Richard Logan, MD
Study Chair
Queen's Medical Centre
United States: Federal Government
CDR0000069273
NCT00033319
May 1997
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