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Sponsored by: |
Queen's Medical Centre |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033319 |
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 | Intervention |
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Colorectal Cancer |
Drug: acetylsalicylic acid Drug: folic acid |
Study Type: | Interventional |
Study Design: | Prevention |
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 |
Study Start Date: | May 1997 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms.
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.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom | |
East Glamorgan Hospital | |
Lhantrisant, United Kingdom, CF72 8XR | |
King's Mills Hospital | |
Nottinghamshire, United Kingdom, NG17 4JL | |
North Manchester Healthcare NHS Trust | |
Manchester, United Kingdom, M8 6RB | |
Selly Oak Hospital | |
Birmingham, United Kingdom, B29 6JD | |
Royal Gwent Hospital | |
Newport Gwent, United Kingdom, NP9 2UB | |
Rotherham District General Hospital-NHS Trust | |
Rotherham, United Kingdom, S60 2UD | |
United Kingdom, England | |
Antrim Hospital | |
Antrim, England, United Kingdom, BR41 2RL | |
Birmingham Heartlands and Solihull NHS Trust (Teaching) | |
Birmingham, England, United Kingdom, B9 5SS | |
Northern General Hospital | |
Sheffield, England, United Kingdom, S5 7AU | |
City Hospital - Birmingham | |
Birmingham, England, United Kingdom, B18 7QH | |
Derby City General Hospital | |
Derby, England, United Kingdom, DE22 3NE | |
Frenchay Hospital | |
Bristol, England, United Kingdom, BS16 1LE | |
Glenfield Hospital | |
Leicester, England, United Kingdom, LE3 9QP | |
Manchester Royal Infirmary | |
Manchester, England, United Kingdom, M13 9WL | |
Merthyr Tydfil Hospital | |
Merthyr, England, United Kingdom | |
Bristol Royal Infirmary | |
Bristol, England, United Kingdom, BS2 8HW | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Queen's Medical Centre | |
Nottingham, England, United Kingdom, NG7 2UH | |
Royal Liverpool and Broadgreen Hospitals | |
Liverpool, England, United Kingdom, L7 8XP | |
Salford Royal Hospitals NHS Trust | |
Salford, England, United Kingdom, M6 8HD | |
Southport and Formby District General Hospital | |
Merseyside, England, United Kingdom, PR8 6NJ | |
Solihull Hospital | |
Solihull, England, United Kingdom, B91 3AH | |
Southmead Hospital | |
Bristol, England, United Kingdom, BS10 5NB | |
Sheffield Teaching Hospitals | |
Sheffield, England, United Kingdom, S1O 2JF | |
Trafford General Hospital | |
Manchester, England, United Kingdom, M31 3SL | |
Whiston Hospital | |
Prescot Merseyside, England, United Kingdom, L35 5DR | |
Wordsley Hospital | |
Dudley, England, United Kingdom, DY8 5QX | |
Wythenshawe Hospital | |
Manchester, England, United Kingdom, M23 9LJ | |
United Kingdom, Northern Ireland | |
Royal Victoria Hospital | |
Belfast, Northern Ireland, United Kingdom, BT12 6BA | |
Whiteabbey Hospital | |
Newtownabbey, Northern Ireland, United Kingdom | |
United Kingdom, Wales | |
Princess of Wales Hospital | |
Bridgend, Wales, United Kingdom, CF31 1JP | |
University of Wales College of Medicine | |
Cardiff, Wales, United Kingdom, CF14 4XN |
Study Chair: | Richard Logan, MD | Queen's Medical Centre |
Study ID Numbers: | CDR0000069273, QMC-UKCAP, EU-20045 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033319 |
Health Authority: | United States: Federal Government |
colon cancer rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Polyps Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Folic Acid Digestive System Diseases Aspirin Gastrointestinal Neoplasms Rectal cancer Adenoma Colorectal Neoplasms |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Neoplasms by Site Sensory System Agents Therapeutic Uses Vitamins Anti-Inflammatory Agents, Non-Steroidal Analgesics Micronutrients |
Vitamin B Complex Hematinics Growth Substances Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |