Study Stopped
The overall program was terminated
Chemoprevention of Colorectal Adenomas
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
1 other identifier
interventional
350
2 countries
39
Brief Summary
The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2007
Typical duration for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 12, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 3, 2020
August 1, 2020
3.4 years
June 12, 2007
August 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation
The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.
156 weeks
Secondary Outcomes (2)
Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug
3 years
Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug
additional 2 years
Study Arms (2)
Active Treatment (calcitriol+ASA+CaCO3)
EXPERIMENTALDaily dose of 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol, Rocaltrol; Roche, Basel, Switzerland), 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3). The daily dose was administered as 1 capsule containing 0.5 mg calcitriol (Rocaltrol; Roche) and 2 tablets containing a 37.5-mg ASA core with a 625-mg calcium carbonate shell (tablet-in-tablet) that was made expressly for this study. Patients should take 1 capsule and 2 tablets daily, together or separately. Timing of the intake is not important; study medication can be taken with or without food. The daily dose should not be exceeded. Before randomization, patients were given the placebo and followed up for a 3-week run-in period. Only patients who showed a placebo medication compliance rate of at least 80% were eligible for randomization. The primary outcome was the proportion of patients with recurrence of any adenomas as detected by colonoscopy after 3 years of treatment.
Placebo to calcitriol+ASA+CaCO3
PLACEBO COMPARATORDaily dose of matching placebo to 0.5 mg calcitriol, 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3). Patients should take 1 capsule and 2 tablets of placebo daily, together or separately. Timing of the intake is not important; study medication can be taken with or without food. The daily dose should not be exceeded. Before randomization, patients were given the placebo and followed up for a 3-week run-in period. Only patients who showed a placebo medication compliance rate of at least 80% were eligible for randomization. The primary outcome was the proportion of patients with recurrence of any adenomas as detected by colonoscopy after 3 years of treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- one adenoma with diameter ≥ 1 cm
- ≥ 2 adenomas of any size
- 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
You may not qualify if:
- 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.
- Cancer within the past 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colotech A/Slead
Study Sites (39)
Alabama Digestive Disorders Center, P.C.
Huntsville, Alabama, 35802, United States
San Diego Digestive Disease Consultants, Inc.
San Diego, California, 92110, United States
Advance Digestive Care
Clearwater, Florida, 33756, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Atlanta Center for Gastroenterology, PC
Decatur, Georgia, 30033, United States
Central Indiana Gastroenterology Group
Anderson, Indiana, 46016, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, 52807, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Gastroenterology Associates of Eastern Maine
Bangor, Maine, 04401, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Office of Alan A. Rosen, M.D.
Baltimore, Maryland, 21215, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Colon and Rectal Surgery Associates, Ltd.
Saint Paul, Minnesota, 55114, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
Gastroenterology Research Associates
Cedar Knolls, New Jersey, 07927, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403, United States
Digestive Health Specialists PA
Winston-Salem, North Carolina, 27103, United States
Northwest Gastroenterology Clinic
Portland, Oregon, 97210, United States
Regional Gastroenterology Associates of Lancaster, Ltd
Lancaster, Pennsylvania, 17604-3200, United States
North Texas Gastroenterology Consultants
Dallas, Texas, 75248, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Advanced Healthcare, S.C.
Milwaukee, Wisconsin, 53209, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Russian Center of Functional Surgical Gastroenterology
Krasnodar, 350086, Russia
Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
Moscow, 105229, Russia
Out-patient clinic No. 2 of the Administration for the President of Russian Federation
Moscow, 119146, Russia
State Medical Stomatological University
Moscow, 127473, Russia
Out-patient clinic No. 3 of the Administration for the President of Russian Federation
Moscow, 129090, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
2nd Terapy Department Military Medical Academy
Saint Petersburg, 193163, Russia
All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
Saint Petersburg, 194044, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
Saint Petersburg, 194291, Russia
Saint-Petersburg State City Hospital No 26
Saint Petersburg, 196247, Russia
Dept of Gastroenterology and Nutrition
Saint Petersburg, 197110, Russia
Smolensk City Clinical Hospital No 1
Smolensk, 214001, Russia
Stavropol State Medical Academy
Stavropol, 355017, Russia
Yaroslav City Clinical Hospital No 2
Yaroslavl, 150010, Russia
Related Publications (2)
Pommergaard HC, Burcharth J, Rosenberg J, Raskov H. Aspirin, Calcitriol, and Calcium Do Not Prevent Adenoma Recurrence in a Randomized Controlled Trial. Gastroenterology. 2016 Jan;150(1):114-122.e4. doi: 10.1053/j.gastro.2015.09.010. Epub 2015 Sep 25.
PMID: 26404953DERIVEDCarroll C, Cooper K, Papaioannou D, Hind D, Pilgrim H, Tappenden P. Supplemental calcium in the chemoprevention of colorectal cancer: a systematic review and meta-analysis. Clin Ther. 2010 May;32(5):789-803. doi: 10.1016/j.clinthera.2010.04.024.
PMID: 20685491DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans Raskov, M.D.
Colotech A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2007
First Posted
June 14, 2007
Study Start
June 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 3, 2020
Record last verified: 2020-08