Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

Study Overview
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Brief Summary
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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
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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.

Official Title
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UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: folic acid
* Drug: acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: folic acid|nan|
|Drug: acetylsalicylic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer