Clinical trial NCT00486512: Chemoprevention of Colorectal Adenomas
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adenomatous Polyps
Keywords: colorectal, adenomas, prevention
Lead sponsor: Colotech A/S
Sponsor class: INDUSTRY
First posted: 2007-06-14
Enrollment: 350
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility 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

Primary outcomes:
measure: Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation
timeFrame: 156 weeks
Secondary outcomes:
measure: Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug
timeFrame: 3 years
measure: Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug
timeFrame: additional 2 years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Digestive Disorders Center, P.C.
state: Alabama
city: San Diego
country: United States
facility: San Diego Digestive Disease Consultants, Inc.
state: California
city: Clearwater
country: United States
facility: Advance Digestive Care
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, PC
state: Georgia
city: Anderson
country: United States
facility: Central Indiana Gastroenterology Group
state: Indiana
city: Davenport
country: United States
facility: Gastrointestinal Clinic of Quad Cities
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Bangor
country: United States
facility: Gastroenterology Associates of Eastern Maine
state: Maine
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Baltimore
country: United States
facility: Office of Alan A. Rosen, M.D.
state: Maryland
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Saint Paul
country: United States
facility: Colon and Rectal Surgery Associates, Ltd.
state: Minnesota
city: Tupelo
country: United States
facility: Digestive Health Specialists, PA
state: Mississippi
city: Cedar Knolls
country: United States
facility: Gastroenterology Research Associates
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists PA
state: North Carolina
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic
state: Oregon
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd
state: Pennsylvania
city: Dallas
country: United States
facility: North Texas Gastroenterology Consultants
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Milwaukee
country: United States
facility: Advanced Healthcare, S.C.
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Krasnodar
country: Russian Federation
facility: Russian Center of Functional Surgical Gastroenterology
city: Moscow
country: Russian Federation
facility: Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
city: Moscow
country: Russian Federation
facility: Out-patient clinic No. 2 of the Administration for the President of Russian Federation
city: Moscow
country: Russian Federation
facility: State Medical Stomatological University
city: Moscow
country: Russian Federation
facility: Out-patient clinic No. 3 of the Administration for the President of Russian Federation
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Dept of Gastroenterology and Nutrition
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State City Hospital No 26
city: Smolensk
country: Russian Federation
facility: Smolensk City Clinical Hospital No 1
city: St. Petersburg
country: Russian Federation
facility: 2nd Terapy Department Military Medical Academy
city: St. Petersburg
country: Russian Federation
facility: All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical Academy
city: Yaroslavl
country: Russian Federation
facility: Yaroslav City Clinical Hospital No 2
Study officials:
affiliation: Colotech A/S
name: Hans Raskov, M.D.
role: STUDY_DIRECTOR
References:
citation: Pommergaard 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.
citation: Carroll 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.