A Clinical Trial Evaluating the Efficacy and Safety of a Combination Treatment Administered Over 3 Years in Patients at Risk of Experiencing Recurrence of Colorectal Adenomas
40 Years
75 Years
Both
Adenomatous Polyps
Trial Information
A Clinical Trial Evaluating the Efficacy and Safety of a Combination Treatment Administered Over 3 Years in Patients at Risk of Experiencing Recurrence of Colorectal Adenomas
This is a multicenter, randomized, parallel group, prospective, double blind, placebo
controlled clinical trial of chemoprevention in patients at increased risk of developing
colorectal cancer (CRC). The Colotech combination treatment (acetylsalicylic acid, 1α
25-dihydroxy cholecalciferol, and calcium carbonate) will be compared to placebo with
regards to safety and efficacy during 3 years of treatment. The randomized treatment period
will be preceded by a 3-week single blind placebo run-in period, which will assess patient's
compliance to treatment. In order to collect data on the durability of treatment effect,
follow-up data from a surveillance colonoscopy will be collected two years after the 3-year
colonoscopy.
Inclusion Criteria:
- Patients 40-75 years of age, both sexes.
- Colonoscopy including the cecum at trial entry
- The removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfill one
of the three following criteria:
1. one adenoma with diameter ≥ 1 cm
2. ≥ 2 adenomas of any size
3. an adenoma of any size and familial disposition for colorectal cancer, as long
as the person is a first degree relative with a colorectal cancer patient
Exclusion Criteria:
- Familial Adenomatous Polyposis Syndrome
- Member of a family with hereditary non-polyposis colorectal cancer (HNPCC)
- Proctocolectomy (colonic and/or rectum resection permitted).
- Inflammatory bowel disease (Crohn´s disease, Ulcerative Colitis).
- Ischemic cardiovascular disease.
- Patients with known gastro-duodenal ulcer at time of inclusion.
- Cancer within the past 5 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
cumulative frequency of recurrence of colorectal adenomas
Outcome Time Frame:
156 weeks
Safety Issue:
No
Principal Investigator
Hans Raskov, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Colotech A/S
Authority:
United States: Food and Drug Administration
Study ID:
COLO CP-01-US
NCT ID:
NCT00486512
Start Date:
June 2007
Completion Date:
June 2012
Related Keywords:
- Adenomatous Polyps
- colorectal, adenomas, prevention
- Adenoma
- Adenomatous Polyps
Name | Location |
|---|---|
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Wisconsin Center for Advanced Research | Milwaukee, Wisconsin 53207 |
| University of Kentucky Medical Center | Lexington, Kentucky 40536-0093 |
| Stony Brook University Medical Center | Stony Brook, New York 11794 |
| Alamo Medical Research | San Antonio, Texas 78215 |
| Alabama Digestive Disorders Center, P.C. | Huntsville, Alabama 35802 |
| San Diego Digestive Disease Consultants, Inc. | San Diego, California 92110 |
| Advance Digestive Care | Clearwater, Florida 33756 |
| Internal Medicine Specialists | Orlando, Florida 32806 |
| Atlanta Center for Gastroenterology, PC | Decatur, Georgia 30033 |
| Central Indiana Gastroenterology Group | Anderson, Indiana 46016 |
| Gastrointestinal Clinic of Quad Cities | Davenport, Iowa 52807 |
| Gastroenterology Associates of Eastern Maine | Bangor, Maine 04401 |
| Digestive Disorders Associates | Annapolis, Maryland 21401 |
| Office of Alan A. Rosen, M.D. | Baltimore, Maryland 21215 |
| Colon and Rectal Surgery Associates, Ltd. | St. Paul, Minnesota 55114 |
| Digestive Health Specialists, PA | Tupelo, Mississippi 38801 |
| Gastroenterology Research Associates | Cedar Knolls, New Jersey 07927 |
| Wilmington Gastroenterology Associates | Wilmington, North Carolina 28403 |
| Digestive Health Specialists PA | Winston-Salem, North Carolina 27103 |
| Northwest Gastroenterology Clinic | Portland, Oregon 97210 |
| Regional Gastroenterology Associates of Lancaster, Ltd | Lancaster, Pennsylvania 17604-3200 |
| North Texas Gastroenterology Consultants | Dallas, Texas 75248 |
| Advanced Healthcare, S.C. | Milwaukee, Wisconsin 53209 |
