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The overall program was terminated
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment (calcitriol+ASA+CaCO3) | Experimental | 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol) | Drug |
| ||
| 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Raskov, M.D. | Colotech A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Digestive Disorders Center, P.C. | Huntsville | Alabama | 35802 | United States | ||
| San Diego Digestive Disease Consultants, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26404953 | Derived | 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. | |
| 20685491 | Derived | 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. |
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| Drug |
|
| placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol) | Drug |
|
| placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) | Drug |
|
| Colonoscopy | Procedure |
|
| 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. | additional 2 years |
| 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 |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| D001241 | Aspirin |
| D002119 | Calcium Carbonate |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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