Chemoprevention of Colorectal Adenomas

Adenomatous Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00486512
• Other study ID #: COLO CP-01-US
• Status: Terminated
• Phase: Phase 3
• Start date: June 2007
• Est. completion date: November 2010

Study information

• Verified date: August 2020
• Source: Colotech A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 350
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps

Intervention

Drug:
• 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)

• 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)

• placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)

• placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)

Procedure:
• Colonoscopy

Locations

Country	Name	City	State
Russian Federation	Russian Center of Functional Surgical Gastroenterology	Krasnodar
Russian Federation	Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"	Moscow
Russian Federation	Out-patient clinic No. 2 of the Administration for the President of Russian Federation	Moscow
Russian Federation	Out-patient clinic No. 3 of the Administration for the President of Russian Federation	Moscow
Russian Federation	State Medical Stomatological University	Moscow
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	Dept of Gastroenterology and Nutrition	Saint Petersburg
Russian Federation	Leningrad Regional Clinical Hospital	Saint-Petersburg
Russian Federation	Saint-Petersburg State City Hospital No 26	Saint-Petersburg
Russian Federation	Smolensk City Clinical Hospital No 1	Smolensk
Russian Federation	2nd Terapy Department Military Medical Academy	St. Petersburg
Russian Federation	All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia	St. Petersburg
Russian Federation	St. Petersburg Central Medical Sanitary Department of Federal Biological Agency	St. Petersburg
Russian Federation	Stavropol State Medical Academy	Stavropol
Russian Federation	Yaroslav City Clinical Hospital No 2	Yaroslavl
United States	Central Indiana Gastroenterology Group	Anderson	Indiana
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Office of Alan A. Rosen, M.D.	Baltimore	Maryland
United States	Gastroenterology Associates of Eastern Maine	Bangor	Maine
United States	Gastroenterology Research Associates	Cedar Knolls	New Jersey
United States	Advance Digestive Care	Clearwater	Florida
United States	North Texas Gastroenterology Consultants	Dallas	Texas
United States	Gastrointestinal Clinic of Quad Cities	Davenport	Iowa
United States	Atlanta Center for Gastroenterology, PC	Decatur	Georgia
United States	Alabama Digestive Disorders Center, P.C.	Huntsville	Alabama
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Regional Gastroenterology Associates of Lancaster, Ltd	Lancaster	Pennsylvania
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Advanced Healthcare, S.C.	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Internal Medicine Specialists	Orlando	Florida
United States	Northwest Gastroenterology Clinic	Portland	Oregon
United States	Colon and Rectal Surgery Associates, Ltd.	Saint Paul	Minnesota
United States	Alamo Medical Research	San Antonio	Texas
United States	San Diego Digestive Disease Consultants, Inc.	San Diego	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Digestive Health Specialists, PA	Tupelo	Mississippi
United States	Wilmington Gastroenterology Associates	Wilmington	North Carolina
United States	Digestive Health Specialists PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Colotech A/S

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 1a 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.	156 weeks
Secondary	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, 1a 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.	3 years
Secondary	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, 1a 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.	additional 2 years