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.

Condition	Treatment or Intervention
prevention of colorectal cancer Colon Cancer Rectal Cancer	Procedure: dietary intervention  Drug: chemoprevention of cancer  Procedure: cancer prevention intervention  Drug: aspirin  Drug: folic acid

Further Study Details: 

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

PROTOCOL 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.

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

Ages Eligible for Study:  up to  75 Years

Criteria

PROTOCOL 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

United Kingdom
      East Glamorgan Hospital, Lhantrisant,  CF72 8XR,  United Kingdom
      King's Mills Hospital, Nottinghamshire,  NG17 4JL,  United Kingdom
      North Manchester Healthcare NHS Trust, Manchester,  M8 6RB,  United Kingdom
      Rotherham District General Hospital-NHS Trust, Rotherham,  S60 2UD,  United Kingdom
      Royal Gwent Hospital, Newport Gwent,  NP9 2UB,  United Kingdom
      Selly Oak Hospital, Birmingham,  B29 6JD,  United Kingdom
United Kingdom, England
      Antrim Hospital, Antrim,  England,  BR41 2RL,  United Kingdom
      Birmingham Heartlands and Solihull NHS Trust (Teaching), Birmingham,  England,  B9 5SS,  United Kingdom
      Bristol Royal Infirmary, Bristol,  England,  BS2 8HW,  United Kingdom
      City Hospital - Birmingham, Birmingham,  England,  B18 7QH,  United Kingdom
      Derby City General Hospital, Derby,  England,  DE22 3NE,  United Kingdom
      Frenchay Hospital, Bristol,  England,  BS16 1LE,  United Kingdom
      Glenfield Hospital, Leicester,  England,  LE3 9QP,  United Kingdom
      Manchester Royal Infirmary, Manchester,  England,  M13 9WL,  United Kingdom
      Merthyr Tydfil Hospital, Merthyr,  England,  United Kingdom
      Northern General Hospital, Sheffield,  England,  S5 7AU,  United Kingdom
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom
      Queen's Medical Centre, Nottingham,  England,  NG7 2UH,  United Kingdom
      Royal Liverpool and Broadgreen Hospitals, Liverpool,  England,  L7 8XP,  United Kingdom
      Salford Royal Hospitals NHS Trust, Salford,  England,  M6 8HD,  United Kingdom
      Sheffield Teaching Hospitals, Sheffield,  England,  S1O 2JF,  United Kingdom
      Solihull Hospital, Solihull,  England,  B91 3AH,  United Kingdom
      Southmead Hospital, Bristol,  England,  BS10 5NB,  United Kingdom
      Southport and Formby District General Hospital, MERSEYSIDE,  England,  PR8 6NJ,  United Kingdom
      Trafford General Hospital, Manchester,  England,  M31 3SL,  United Kingdom
      Whiston Hospital, Prescot Merseyside,  England,  L35 5DR,  United Kingdom
      Wordsley Hospital, Dudley,  England,  DY8 5QX,  United Kingdom
      Wythenshawe Hospital, Manchester,  England,  M23 9LJ,  United Kingdom
United Kingdom, Northern Ireland
      Royal Victoria Hospital, Belfast,  Northern Ireland,  BT12 6BA,  United Kingdom
      Whiteabbey Hospital, Newtownabbey,  Northern Ireland,  United Kingdom
United Kingdom, Wales
      Princess of Wales Hospital, Bridgend,  Wales,  CF31 1JP,  United Kingdom
      University of Wales College of Medicine, Cardiff,  Wales,  CF14 4XN,  United Kingdom

Study chairs or principal investigators

Richard Logan,  Study Chair,  Queen's Medical Centre   

Study ID Numbers:  CDR0000069273; QMC-UKCAP; EU-20045
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033319
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08