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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00033319
Other study ID # CDR0000069273
Secondary ID QMC-UKCAPEU-2004
Status Active, not recruiting
Phase N/A
First received April 9, 2002
Last updated September 16, 2013
Start date May 1997

Study information

Verified date December 2002
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 75 Years
Eligibility 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)

Study Design

Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
folic acid

Drug:
acetylsalicylic acid


Locations

Country Name City State
United Kingdom Antrim Hospital Antrim England
United Kingdom Royal Victoria Hospital Belfast Northern Ireland
United Kingdom Birmingham Heartlands and Solihull NHS Trust (Teaching) Birmingham England
United Kingdom City Hospital - Birmingham Birmingham England
United Kingdom Selly Oak Hospital Birmingham
United Kingdom Princess of Wales Hospital Bridgend Wales
United Kingdom Bristol Royal Infirmary Bristol England
United Kingdom Frenchay Hospital Bristol England
United Kingdom Southmead Hospital Bristol England
United Kingdom University of Wales College of Medicine Cardiff Wales
United Kingdom Derby City General Hospital Derby England
United Kingdom Wordsley Hospital Dudley England
United Kingdom Glenfield Hospital Leicester England
United Kingdom East Glamorgan Hospital Lhantrisant
United Kingdom Royal Liverpool and Broadgreen Hospitals Liverpool England
United Kingdom Manchester Royal Infirmary Manchester England
United Kingdom North Manchester Healthcare NHS Trust Manchester
United Kingdom Trafford General Hospital Manchester England
United Kingdom Wythenshawe Hospital Manchester England
United Kingdom Southport and Formby District General Hospital Merseyside England
United Kingdom Merthyr Tydfil Hospital Merthyr England
United Kingdom Royal Gwent Hospital Newport Gwent
United Kingdom Whiteabbey Hospital Newtownabbey Northern Ireland
United Kingdom Nottingham City Hospital NHS Trust Nottingham England
United Kingdom Queen's Medical Centre Nottingham England
United Kingdom King's Mills Hospital Nottinghamshire
United Kingdom Whiston Hospital Prescot Merseyside England
United Kingdom Rotherham District General Hospital-NHS Trust Rotherham
United Kingdom Salford Royal Hospitals NHS Trust Salford England
United Kingdom Northern General Hospital Sheffield England
United Kingdom Sheffield Teaching Hospitals Sheffield England
United Kingdom Solihull Hospital Solihull England

Sponsors (1)

Lead Sponsor Collaborator
Queen's Medical Centre

Country where clinical trial is conducted

United Kingdom, 

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