Clinical trial NCT00033319: Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-07-01
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Antrim Hospital
state: England
city: Birmingham
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)
state: England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
state: England
city: Derby
country: United Kingdom
facility: Derby City General Hospital
state: England
city: Dudley
country: United Kingdom
facility: Wordsley Hospital
state: England
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen Hospitals
state: England
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: England
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: England
city: Manchester
country: United Kingdom
facility: Trafford General Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Southport and Formby District General Hospital
state: England
city: Merthyr
country: United Kingdom
facility: Merthyr Tydfil Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Prescot Merseyside
country: United Kingdom
facility: Whiston Hospital
state: England
city: Salford
country: United Kingdom
facility: Salford Royal Hospitals NHS Trust
state: England
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: England
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: England
city: Solihull
country: United Kingdom
facility: Solihull Hospital
state: England
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
state: Northern Ireland
city: Newtownabbey
country: United Kingdom
facility: Whiteabbey Hospital
state: Northern Ireland
city: Bridgend
country: United Kingdom
facility: Princess of Wales Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: University of Wales College of Medicine
state: Wales
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital
city: Lhantrisant
country: United Kingdom
facility: East Glamorgan Hospital
city: Manchester
country: United Kingdom
facility: North Manchester Healthcare NHS Trust
city: Newport Gwent
country: United Kingdom
facility: Royal Gwent Hospital
city: Nottinghamshire
country: United Kingdom
facility: King's Mills Hospital
city: Rotherham
country: United Kingdom
facility: Rotherham District General Hospital-NHS Trust
Study officials:
affiliation: Queen's Medical Center
name: Richard Logan, MD
role: STUDY_CHAIR
References: