Chemoprevention of Colorectal Adenomas
- Conditions
- Adenomatous Polyps
- Interventions
- Drug: placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)Drug: 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)Drug: placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)Drug: 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)Procedure: Colonoscopy
- Registration Number
- NCT00486512
- Lead Sponsor
- Colotech A/S
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 350
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment (calcitriol+ASA+CaCO3) Colonoscopy Daily 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 to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol) Daily 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. Placebo to calcitriol+ASA+CaCO3 placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) Daily 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. Active Treatment (calcitriol+ASA+CaCO3) 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol) Daily 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. Active Treatment (calcitriol+ASA+CaCO3) 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) Daily 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 Colonoscopy Daily 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.
- Primary Outcome Measures
Name Time Method Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation 156 weeks 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.
- Secondary Outcome Measures
Name Time Method Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug 3 years 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.
Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug additional 2 years 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.
Trial Locations
- Locations (39)
Central Indiana Gastroenterology Group
🇺🇸Anderson, Indiana, United States
Atlanta Center for Gastroenterology, PC
🇺🇸Decatur, Georgia, United States
Gastroenterology Associates of Eastern Maine
🇺🇸Bangor, Maine, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Out-patient clinic No. 3 of the Administration for the President of Russian Federation
🇷🇺Moscow, Russian Federation
St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
🇷🇺St. Petersburg, Russian Federation
San Diego Digestive Disease Consultants, Inc.
🇺🇸San Diego, California, United States
Northwest Gastroenterology Clinic
🇺🇸Portland, Oregon, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Russian Center of Functional Surgical Gastroenterology
🇷🇺Krasnodar, Russian Federation
Dept of Gastroenterology and Nutrition
🇷🇺Saint Petersburg, Russian Federation
Alabama Digestive Disorders Center, P.C.
🇺🇸Huntsville, Alabama, United States
Digestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
Gastrointestinal Clinic of Quad Cities
🇺🇸Davenport, Iowa, United States
Office of Alan A. Rosen, M.D.
🇺🇸Baltimore, Maryland, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Colon and Rectal Surgery Associates, Ltd.
🇺🇸Saint Paul, Minnesota, United States
Digestive Health Specialists, PA
🇺🇸Tupelo, Mississippi, United States
Wilmington Gastroenterology Associates
🇺🇸Wilmington, North Carolina, United States
Regional Gastroenterology Associates of Lancaster, Ltd
🇺🇸Lancaster, Pennsylvania, United States
Advanced Healthcare, S.C.
🇺🇸Milwaukee, Wisconsin, United States
North Texas Gastroenterology Consultants
🇺🇸Dallas, Texas, United States
Saint-Petersburg State City Hospital No 26
🇷🇺Saint-Petersburg, Russian Federation
State Medical Stomatological University
🇷🇺Moscow, Russian Federation
2nd Terapy Department Military Medical Academy
🇷🇺St. Petersburg, Russian Federation
Yaroslav City Clinical Hospital No 2
🇷🇺Yaroslavl, Russian Federation
Smolensk City Clinical Hospital No 1
🇷🇺Smolensk, Russian Federation
Out-patient clinic No. 2 of the Administration for the President of Russian Federation
🇷🇺Moscow, Russian Federation
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
🇷🇺St. Petersburg, Russian Federation
Stavropol State Medical Academy
🇷🇺Stavropol, Russian Federation
Advance Digestive Care
🇺🇸Clearwater, Florida, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Digestive Health Specialists PA
🇺🇸Winston-Salem, North Carolina, United States
Gastroenterology Research Associates
🇺🇸Cedar Knolls, New Jersey, United States
Leningrad Regional Clinical Hospital
🇷🇺Saint-Petersburg, Russian Federation
Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
🇷🇺Moscow, Russian Federation
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States