Adenomatous Polyps
Conditions
Keywords
colorectal, adenomas, prevention
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.
Interventions
DRUG0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
DRUG75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
DRUGplacebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
DRUGplacebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
PROCEDUREColonoscopy
Sponsors
Colotech A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Russia, United States
Outcome results
None listed