Chemoprevention of Colorectal Adenomas

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colotech A/S
• Treatments: Aspirin; Calcitriol; Calcium; Calcium Carbonate; Calcium, Dietary; Dihydroxycholecalciferols

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:

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