UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
N/A
75 Years
Both
Colorectal Cancer
Trial Information
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.
Inclusion 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)
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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
Richard Logan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Queen's Medical Centre
Authority:
United States: Federal Government
Study ID:
CDR0000069273
NCT ID:
NCT00033319
Start Date:
May 1997
Completion Date:
Related Keywords:
- Colorectal Cancer
- colon cancer
- rectal cancer
- Colorectal Neoplasms
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