Chemoprevention of Colorectal Adenomas

August 31, 2020 updated by: Colotech A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Krasnodar, Russian Federation, 350086
        • Russian Center of Functional Surgical Gastroenterology
      • Moscow, Russian Federation, 105229
        • Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
      • Moscow, Russian Federation, 119146
        • Out-patient clinic No. 2 of the Administration for the President of Russian Federation
      • Moscow, Russian Federation, 127473
        • State Medical Stomatological University
      • Moscow, Russian Federation, 129090
        • Out-patient clinic No. 3 of the Administration for the President of Russian Federation
      • Rostov-on-Don, Russian Federation, 344022
        • Rostov State Medical University
      • Saint Petersburg, Russian Federation, 197110
        • Dept of Gastroenterology and Nutrition
      • Saint-Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
      • Saint-Petersburg, Russian Federation, 196247
        • Saint-Petersburg State City Hospital No 26
      • Smolensk, Russian Federation, 214001
        • Smolensk City Clinical Hospital No 1
      • St. Petersburg, Russian Federation, 193163
        • 2nd Terapy Department Military Medical Academy
      • St. Petersburg, Russian Federation, 194044
        • All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
      • St. Petersburg, Russian Federation, 194291
        • St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
      • Stavropol, Russian Federation, 355017
        • Stavropol State Medical Academy
      • Yaroslavl, Russian Federation, 150010
        • Yaroslav City Clinical Hospital No 2
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Alabama Digestive Disorders Center, P.C.
    • California
      • San Diego, California, United States, 92110
        • San Diego Digestive Disease Consultants, Inc.
    • Florida
      • Clearwater, Florida, United States, 33756
        • Advance Digestive Care
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta Center for Gastroenterology, PC
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Central Indiana Gastroenterology Group
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Gastrointestinal Clinic of Quad Cities
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Maine
      • Bangor, Maine, United States, 04401
        • Gastroenterology Associates of Eastern Maine
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Digestive Disorders Associates
      • Baltimore, Maryland, United States, 21215
        • Office of Alan A. Rosen, M.D.
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Colon and Rectal Surgery Associates, Ltd.
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists, PA
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • Gastroenterology Research Associates
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Wilmington, North Carolina, United States, 28403
        • Wilmington Gastroenterology Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists PA
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Gastroenterology Clinic
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
        • Regional Gastroenterology Associates of Lancaster, Ltd
    • Texas
      • Dallas, Texas, United States, 75248
        • North Texas Gastroenterology Consultants
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare, S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Treatment (calcitriol+ASA+CaCO3)
Daily dose of 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol, Rocaltrol; Roche, Basel, Switzerland), 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3). The daily dose was administered as 1 capsule containing 0.5 mg calcitriol (Rocaltrol; Roche) and 2 tablets containing a 37.5-mg ASA core with a 625-mg calcium carbonate shell (tablet-in-tablet) that was made expressly for this study. Patients should take 1 capsule and 2 tablets daily, together or separately. Timing of the intake is not important; study medication can be taken with or without food. The daily dose should not be exceeded. Before randomization, patients were given the placebo and followed up for a 3-week run-in period. Only patients who showed a placebo medication compliance rate of at least 80% were eligible for randomization. The primary outcome was the proportion of patients with recurrence of any adenomas as detected by colonoscopy after 3 years of treatment.
Procedure: Colonoscopy
Drug: 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
Drug: 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
Placebo Comparator: Placebo to calcitriol+ASA+CaCO3
Daily dose of matching placebo to 0.5 mg calcitriol, 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3). Patients should take 1 capsule and 2 tablets of placebo daily, together or separately. Timing of the intake is not important; study medication can be taken with or without food. The daily dose should not be exceeded. Before randomization, patients were given the placebo and followed up for a 3-week run-in period. Only patients who showed a placebo medication compliance rate of at least 80% were eligible for randomization. The primary outcome was the proportion of patients with recurrence of any adenomas as detected by colonoscopy after 3 years of treatment.
Procedure: Colonoscopy
Drug: placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
Drug: placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation
Time Frame: 156 weeks
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 which were removed during colonoscopy.
156 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug
Time Frame: 3 years
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 which were removed during colonoscopy.
3 years
Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug
Time Frame: additional 2 years
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 which were removed during colonoscopy.
additional 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colotech A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hans Raskov, M.D., Colotech A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COLO CP-01-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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