Randomized Study of Aspirin and/or Folic Acid as Prevention of Recurrent Colorectal Adenomas in Patients Who Have Had Colorectal Adenomas Removed. 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.

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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

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedPreventionClosed75 and underOtherQMC-UKCAP
EU-20045, NCT00033319

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 TitleUKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
Trial Start Date1997-05-01
Registered in ClinicalTrials.govNCT00033319
Date Submitted to PDQ2002-02-06
Information Last Verified2002-12-16

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.