This trial is active, not recruiting.

Condition colorectal cancer
Treatments folic acid, acetylsalicylic acid
Sponsor Queen's Medical Centre
Start date May 1997
Trial identifier NCT00033319, CDR0000069273, EU-20045, QMC-UKCAP


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose prevention

Eligibility Criteria

Male or female participants up to 75 years old.

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)

Additional Information

Official title UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).