Chemoprevention of Colorectal Adenomas

This study has been terminated.
(Planned Interim Analysis failed to show difference between the active and placebo groups)
Sponsor:
Information provided by:
Colotech A/S
ClinicalTrials.gov Identifier:
NCT00486512
First received: June 12, 2007
Last updated: February 4, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Adenomatous Polyps
Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Colotech A/S:

Primary Outcome Measures:
  • cumulative frequency of recurrence of colorectal adenomas [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number and size of colorectal adenomas measured after three years of using the study drug [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • durability of treatment effect for two years post-treatment [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
aspirin, 1,25-dihydroxycholecalciferol, calcium
Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium
Oral Calcitriol (1α 25-dihydroxy cholecalciferol) capsules, 0.5 µg (QD) Oral acetylsalicylic acid 37.5 mg and calcium carbonate 625 mg combination tablets (bid)
Placebo Comparator: 2
placebo to aspirin, 1,25-dihydroxycholecalciferol, calcium
Drug: placebo
placebo to oral Calcitriol (1α 25-dihydroxy cholecalciferol) capsules, 0.5 µg (QD) placebo to oral acetylsalicylic acid 37.5 mg and calcium carbonate 625 mg combination tablets (bid)

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486512

  Show 39 Study Locations
Sponsors and Collaborators
Colotech A/S
Investigators
Study Director: Hans Raskov, M.D. Colotech A/S
  More Information

No publications provided by Colotech A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jurij Petrin, MD, Colotech A/S, Denmark
ClinicalTrials.gov Identifier: NCT00486512     History of Changes
Other Study ID Numbers: COLO CP-01-US
Study First Received: June 12, 2007
Last Updated: February 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Colotech A/S:
colorectal, adenomas, prevention

Additional relevant MeSH terms:
Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Aspirin
Calcitriol
Dihydroxycholecalciferols
Calcium, Dietary
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Vitamins

ClinicalTrials.gov processed this record on July 22, 2014