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

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.

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