Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

Objectives

1. Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed.

Entry 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)

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)

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

Expected Enrollment

A total of 1,300 patients will be accrued for this study.

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

Trial Contact Information

Trial Lead Organizations

Queen's Medical Centre

Richard Logan, MD, Protocol chair		Ph: 44-115-924-9924 Email: richard.logan@nottingham.ac.uk

Registry 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
Trial Start Date		1997-05-01
Registered in ClinicalTrials.gov		NCT00033319
Date Submitted to PDQ		2002-02-06
Information Last Verified		2002-12-16

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