Clinical trial · Interventional
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
NCT00486512CI-TRIAL-00046944terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The overall program was terminated
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol) | Drug | — | UNRESOLVED |
| 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) | Drug | — | UNRESOLVED |
| Colonoscopy | Procedure | — | UNRESOLVED |
| placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol) | Drug | — | UNRESOLVED |
| placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Treatment (calcitriol+ASA+CaCO3)
- 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.
- interventionNames
- Drug: 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
- Drug: 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
- Procedure: Colonoscopy
- type
- PLACEBO_COMPARATOR
- label
- Placebo to calcitriol+ASA+CaCO3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPommergaard 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 26404953
- DERIVEDCarroll 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 20685491