Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
NCT ID: NCT00033319
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
1997-05-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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PREVENTION
Interventions
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folic acid
acetylsalicylic acid
Eligibility Criteria
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Inclusion Criteria
* 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)
75 Years
ALL
No
Sponsors
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Queen's Medical Center
OTHER
Principal Investigators
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Richard Logan, MD
Role: STUDY_CHAIR
Queen's Medical Center
Locations
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Antrim Hospital
Antrim, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
Frenchay Hospital
Bristol, England, United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom
Derby City General Hospital
Derby, England, United Kingdom
Wordsley Hospital
Dudley, England, United Kingdom
Glenfield Hospital
Leicester, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Wythenshawe Hospital
Manchester, England, United Kingdom
Trafford General Hospital
Manchester, England, United Kingdom
Southport and Formby District General Hospital
Merseyside, England, United Kingdom
Merthyr Tydfil Hospital
Merthyr, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Whiston Hospital
Prescot Merseyside, England, United Kingdom
Salford Royal Hospitals NHS Trust
Salford, England, United Kingdom
Sheffield Teaching Hospitals
Sheffield, England, United Kingdom
Northern General Hospital
Sheffield, England, United Kingdom
Solihull Hospital
Solihull, England, United Kingdom
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom
Whiteabbey Hospital
Newtownabbey, Northern Ireland, United Kingdom
Princess of Wales Hospital
Bridgend, Wales, United Kingdom
University of Wales College of Medicine
Cardiff, Wales, United Kingdom
Selly Oak Hospital
Birmingham, , United Kingdom
East Glamorgan Hospital
Lhantrisant, , United Kingdom
North Manchester Healthcare NHS Trust
Manchester, , United Kingdom
Royal Gwent Hospital
Newport Gwent, , United Kingdom
King's Mills Hospital
Nottinghamshire, , United Kingdom
Rotherham District General Hospital-NHS Trust
Rotherham, , United Kingdom
Countries
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Other Identifiers
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QMC-UKCAP
Identifier Type: -
Identifier Source: secondary_id
EU-20045
Identifier Type: -
Identifier Source: secondary_id
CDR0000069273
Identifier Type: -
Identifier Source: org_study_id