Back to resultsChemoprevention of Colorectal Adenomas
Primary Purpose
Adenomatous Polyps
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
Colonoscopy
Sponsored by
About this trial
This is an interventional prevention trial for Adenomatous Polyps focused on measuring colorectal, adenomas, prevention
Eligibility Criteria
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:
- 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
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
Sites / Locations
- Alabama Digestive Disorders Center, P.C.
- San Diego Digestive Disease Consultants, Inc.
- Advance Digestive Care
- Internal Medicine Specialists
- Atlanta Center for Gastroenterology, PC
- Central Indiana Gastroenterology Group
- Gastrointestinal Clinic of Quad Cities
- University of Kentucky Medical Center
- Gastroenterology Associates of Eastern Maine
- Digestive Disorders Associates
- Office of Alan A. Rosen, M.D.
- Borgess Medical Center
- Colon and Rectal Surgery Associates, Ltd.
- Digestive Health Specialists, PA
- Gastroenterology Research Associates
- Stony Brook University Medical Center
- Wilmington Gastroenterology Associates
- Digestive Health Specialists PA
- Northwest Gastroenterology Clinic
- Regional Gastroenterology Associates of Lancaster, Ltd
- North Texas Gastroenterology Consultants
- Alamo Medical Research
- Advanced Healthcare, S.C.
- Wisconsin Center for Advanced Research
- Russian Center of Functional Surgical Gastroenterology
- Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
- Out-patient clinic No. 2 of the Administration for the President of Russian Federation
- State Medical Stomatological University
- Out-patient clinic No. 3 of the Administration for the President of Russian Federation
- Rostov State Medical University
- Dept of Gastroenterology and Nutrition
- Leningrad Regional Clinical Hospital
- Saint-Petersburg State City Hospital No 26
- Smolensk City Clinical Hospital No 1
- 2nd Terapy Department Military Medical Academy
- All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
- St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
- Stavropol State Medical Academy
- Yaroslav City Clinical Hospital No 2
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Treatment (calcitriol+ASA+CaCO3)
Placebo to calcitriol+ASA+CaCO3
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00486512
Brief Title
Chemoprevention of Colorectal Adenomas
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
The overall program was terminated
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colotech A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
colorectal, adenomas, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment (calcitriol+ASA+CaCO3)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo to calcitriol+ASA+CaCO3
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
Intervention Type
Drug
Intervention Name(s)
75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
Intervention Type
Drug
Intervention Name(s)
placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
Intervention Type
Drug
Intervention Name(s)
placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Primary Outcome Measure Information:
Title
Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation
Description
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.
Time Frame
156 weeks
Secondary Outcome Measure Information:
Title
Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug
Description
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.
Time Frame
3 years
Title
Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug
Description
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.
Time Frame
additional 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Raskov, M.D.
Organizational Affiliation
Colotech A/S
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Digestive Disorders Center, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
San Diego Digestive Disease Consultants, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Facility Name
Advance Digestive Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Atlanta Center for Gastroenterology, PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Central Indiana Gastroenterology Group
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Gastrointestinal Clinic of Quad Cities
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Gastroenterology Associates of Eastern Maine
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Digestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Office of Alan A. Rosen, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Colon and Rectal Surgery Associates, Ltd.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Gastroenterology Research Associates
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wilmington Gastroenterology Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Digestive Health Specialists PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Northwest Gastroenterology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster, Ltd
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604-3200
Country
United States
Facility Name
North Texas Gastroenterology Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75248
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Advanced Healthcare, S.C.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Russian Center of Functional Surgical Gastroenterology
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Out-patient clinic No. 2 of the Administration for the President of Russian Federation
City
Moscow
ZIP/Postal Code
119146
Country
Russian Federation
Facility Name
State Medical Stomatological University
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Out-patient clinic No. 3 of the Administration for the President of Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Dept of Gastroenterology and Nutrition
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Saint-Petersburg State City Hospital No 26
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Smolensk City Clinical Hospital No 1
City
Smolensk
ZIP/Postal Code
214001
Country
Russian Federation
Facility Name
2nd Terapy Department Military Medical Academy
City
St. Petersburg
ZIP/Postal Code
193163
Country
Russian Federation
Facility Name
All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Stavropol State Medical Academy
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Yaroslav City Clinical Hospital No 2
City
Yaroslavl
ZIP/Postal Code
150010
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
26404953
Citation
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.
Results Reference
derived
PubMed Identifier
20685491
Citation
Carroll 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.
Results Reference
derived
Learn more about this trial
Chemoprevention of Colorectal Adenomas
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