Colorectal CancerNCT00033319
Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
A study testing folic acid and acetylsalicylic acid in people with Colorectal Cancer, run by Queen's Medical Center at 32 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- folic acid and acetylsalicylic acid
- How many people
- Not given
- Where
- 32 sitesUnited Kingdom
- Study dates
- May 1997to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United Kingdom32 sites
Antrim Hospital
Antrim, England, BR41 2RL
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
City Hospital - Birmingham
Birmingham, England, B18 7QH
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, B9 5SS
Selly Oak Hospital
Birmingham, B29 6JD
Princess of Wales Hospital
Bridgend, Wales, CF31 1JP
Southmead Hospital
Bristol, England, BS10 5NB
Frenchay Hospital
Bristol, England, BS16 1LE
Bristol Royal Infirmary
Bristol, England, BS2 8HW
University of Wales College of Medicine
Cardiff, Wales, CF14 4XN
Derby City General Hospital
Derby, England, DE22 3NE
Wordsley Hospital
Dudley, England, DY8 5QX
Glenfield Hospital
Leicester, England, LE3 9QP
East Glamorgan Hospital
Lhantrisant, CF72 8XR
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, L7 8XP
Manchester Royal Infirmary
Manchester, England, M13 9WL
Wythenshawe Hospital
Manchester, England, M23 9LJ
Trafford General Hospital
Manchester, England, M31 3SL
North Manchester Healthcare NHS Trust
Manchester, M8 6RB
Southport and Formby District General Hospital
Merseyside, England, PR8 6NJ
Merthyr Tydfil Hospital
Merthyr, England
Royal Gwent Hospital
Newport Gwent, NP9 2UB
Whiteabbey Hospital
Newtownabbey, Northern Ireland
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Queen's Medical Centre
Nottingham, England, NG7 2UH
King's Mills Hospital
Nottinghamshire, NG17 4JL
Whiston Hospital
Prescot Merseyside, England, L35 5DR
Rotherham District General Hospital-NHS Trust
Rotherham, S60 2UD
Salford Royal Hospitals NHS Trust
Salford, England, M6 8HD
Sheffield Teaching Hospitals
Sheffield, England, S1O 2JF
Northern General Hospital
Sheffield, England, S5 7AU
Solihull Hospital
Solihull, England, B91 3AH
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- folic acid, acetylsalicylic acid
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDietary supplement
acetylsalicylic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2003 (estimated)
- Study startMay 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Richard Logan, MD, Study chair, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033319
- Sponsor's protocol ID
- CDR0000069273
- Other IDs
- QMC-UKCAP, EU-20045
- Status last verified
- Dec 2002
- First submitted
- 9 Apr 2002
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00033319
- Acronym / sponsor ID
- CDR0000069273
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Study start
- May 1997
- First posted
- 1 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acid | Dietary supplement | – |
| acetylsalicylic acid | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Logan, MD study chair
Queen's Medical Center
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing folic acid and acetylsalicylic acid in people with Colorectal Cancer, run by Queen's Medical Center at 32 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.