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Adenomatous PolypsPhase 3NCT00486512

Chemoprevention of Colorectal Adenomas

A Phase 3 study testing 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol), 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) and Colonoscopy in people with Adenomatous Polyps, run by Colotech A/S at 39 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Adenomatous Polyps
What is being tested?
0.5 mg calcitriol (1a -25-dihydroxycholecalciferol), 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) and Colonoscopy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
39 sitesin 2 countries
Study dates
Jun 2007to Nov 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • one adenoma with diameter ≥ 1 cm
  • ≥ 2 adenomas of any size
  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States24 sites

  • Central Indiana Gastroenterology Group

    Anderson, Indiana, 46016

  • Digestive Disorders Associates

    Annapolis, Maryland, 21401

  • Office of Alan A. Rosen, M.D.

    Baltimore, Maryland, 21215

  • Gastroenterology Associates of Eastern Maine

    Bangor, Maine, 04401

  • Gastroenterology Research Associates

    Cedar Knolls, New Jersey, 07927

  • Advance Digestive Care

    Clearwater, Florida, 33756

  • North Texas Gastroenterology Consultants

    Dallas, Texas, 75248

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52807

  • Atlanta Center for Gastroenterology, PC

    Decatur, Georgia, 30033

  • Alabama Digestive Disorders Center, P.C.

    Huntsville, Alabama, 35802

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Regional Gastroenterology Associates of Lancaster, Ltd

    Lancaster, Pennsylvania, 17604-3200

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Advanced Healthcare, S.C.

    Milwaukee, Wisconsin, 53209

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Northwest Gastroenterology Clinic

    Portland, Oregon, 97210

  • Colon and Rectal Surgery Associates, Ltd.

    Saint Paul, Minnesota, 55114

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • San Diego Digestive Disease Consultants, Inc.

    San Diego, California, 92110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Digestive Health Specialists, PA

    Tupelo, Mississippi, 38801

  • Wilmington Gastroenterology Associates

    Wilmington, North Carolina, 28403

  • Digestive Health Specialists PA

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia15 sites

  • Russian Center of Functional Surgical Gastroenterology

    Krasnodar, 350086

  • Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"

    Moscow, 105229

  • Out-patient clinic No. 2 of the Administration for the President of Russian Federation

    Moscow, 119146

  • State Medical Stomatological University

    Moscow, 127473

  • Out-patient clinic No. 3 of the Administration for the President of Russian Federation

    Moscow, 129090

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • 2nd Terapy Department Military Medical Academy

    Saint Petersburg, 193163

  • All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia

    Saint Petersburg, 194044

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • St. Petersburg Central Medical Sanitary Department of Federal Biological Agency

    Saint Petersburg, 194291

  • Saint-Petersburg State City Hospital No 26

    Saint Petersburg, 196247

  • Dept of Gastroenterology and Nutrition

    Saint Petersburg, 197110

  • Smolensk City Clinical Hospital No 1

    Smolensk, 214001

  • Stavropol State Medical Academy

    Stavropol, 355017

  • Yaroslav City Clinical Hospital No 2

    Yaroslavl, 150010

Other trials in Russia

About this study

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

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.

Read the 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.

Being tested
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), Colonoscopy
Keywords
colorectal, adenomas, prevention
Medical subject headings
Adenomatous Polyps, Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

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

  • ColonoscopyProcedure or surgery

Study groups in NCT00486512
Study groupRoleWhat they receive
Active Treatment (calcitriol+ASA+CaCO3)ExperimentalDaily 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.
Receives: Drug: 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol); Drug: 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3); Procedure: Colonoscopy
Placebo to calcitriol+ASA+CaCO3Placebo comparatorDaily 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.
Receives: Drug: placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol); Drug: placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3); Procedure: Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.

    Measured: 156 weeks

Secondary outcomes (2)

  1. 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, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.

    Measured: 3 years

  2. 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, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy.

    Measured: additional 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionNov 2010
  4. Study completionNov 2010

Why it stopped: The overall program was terminated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00486512
Sponsor's protocol ID
COLO CP-01-US
Status last verified
Aug 2020
First submitted
12 Jun 2007
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26404953

  • 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.

    PubMed 20685491

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol), 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3) and Colonoscopy in people with Adenomatous Polyps, run by Colotech A/S at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The overall program was terminated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation (time frame: 156 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00486512, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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