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Research Article

Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention

Patricia Thompson, Denise Roe, Liane Fales, Julie Buckmeier, Fang Wang, Stanley R. Hamilton, Achyut Bhattacharyya, Sylvan B. Green, Chiu-Hsieh Hsu, H-H. Sherry Chow, Dennis J. Ahnen, C. Richard Boland, Russell I. Heigh, David E. Fay, Elena Martinez, Elizabeth Jacobs, Erin L. Ashbeck, David S. Alberts and Peter Lance
Patricia Thompson
Epidemiology, University of Arizona Cancer Center
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Denise Roe
Epidemiology and Biostatistics, University of Arizona
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Liane Fales
University of Arizona Cancer Center, University of Arizona
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Julie Buckmeier
Arizona Cancer Center, University of Arizona
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Fang Wang
Univeristy of Arizona Cancer Center, University of Arizona
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Stanley R. Hamilton
Pathology and Laboratory Medicine, MD Anderson Cancer Center
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Achyut Bhattacharyya
Pathology, University of Arizona
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Sylvan B. Green
Biostatistics, University of Arizona Cancer Center
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Chiu-Hsieh Hsu
Epidemiology and Biostatistics, University of Arizona
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H-H. Sherry Chow
Arizona Cancer Center, University of Arizona
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Dennis J. Ahnen
Medicine, University of Colorado
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C. Richard Boland
Internal Medicine/Gastroenterology, Baylor University Medical Center
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Russell I. Heigh
Gastroenterology, Mayo Clinic
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David E. Fay
Gastroenterology Associates, LLP, Endoscopy Center of Western New York
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Elena Martinez
Professor, Department of Family & Preventive Medicine, Moores UCSD Cancer Center
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Elizabeth Jacobs
University of Arizona Cancer Center, University of Arizona
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Erin L. Ashbeck
Arizona Cancer Center, University of Arizona
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David S. Alberts
Arizona Cancer Center, University of Arizona
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Peter Lance
University of Arizona Cancer Center, University of Arizona
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DOI: 10.1158/1940-6207.CAPR-12-0204
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Abstract

Cyclooxygenase (COX) inhibitors reduce colorectal adenoma recurrence by up to 45% and selenium supplementation may prevent colorectal cancer. Following colonoscopic adenoma resection, 1,600 men and women aged 40-80 years were randomized to celecoxib (400 mg daily), a selective COX-2 inhibitor, and/or selenium (200 µg daily as selenized yeast), or double placebo. The trial was initiated in November, 2001. The primary trial endpoint is adenoma recurrence in each intervention group compared to placebo, as determined by surveillance colonoscopy performed 3-5 years after baseline. Randomization was stratified by use of low-dose aspirin (81 mg) and clinic site. Following reports of cardiovascular toxicity associated with COX-2 inhibitors, the celecoxib arm was discontinued in December, 2004 when 824 participants had been randomized. Accrual continued with randomization to selenium alone or placebo. Randomization of the originally planned cohort (n=1,621) was completed in November, 2008. A further 200 patients with 1+ advanced adenomas (denoting increased risk for colorectal cancer) were accrued to enhance statistical power for determining intervention efficacy in this higher-risk subgroup. Accrual of the total cohort (n=1,824) was completed in January, 2011. Baseline cohort characteristics include: mean age 62.9 years; 65% male; BMI 29.1 ±5.1; 47% taking low-dose aspirin while on trial; 20% with 3+ adenomas; and 38% with advanced adenomas. Intervention effects on adenoma recurrence will be determined, and their modification by genetic background and baseline selenium level. The effect of selenium supplementation on risk for type 2 diabetes will also be reported (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00078897.)

  • Received May 16, 2012.
  • Revision received September 20, 2012.
  • Accepted September 24, 2012.
  • Copyright © 2012, American Association for Cancer Research.
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Published OnlineFirst October 11, 2012
doi: 10.1158/1940-6207.CAPR-12-0204

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Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention
Patricia Thompson, Denise Roe, Liane Fales, Julie Buckmeier, Fang Wang, Stanley R. Hamilton, Achyut Bhattacharyya, Sylvan B. Green, Chiu-Hsieh Hsu, H-H. Sherry Chow, Dennis J. Ahnen, C. Richard Boland, Russell I. Heigh, David E. Fay, Elena Martinez, Elizabeth Jacobs, Erin L. Ashbeck, David S. Alberts and Peter Lance
Cancer Prev Res October 11 2012 DOI: 10.1158/1940-6207.CAPR-12-0204

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Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention
Patricia Thompson, Denise Roe, Liane Fales, Julie Buckmeier, Fang Wang, Stanley R. Hamilton, Achyut Bhattacharyya, Sylvan B. Green, Chiu-Hsieh Hsu, H-H. Sherry Chow, Dennis J. Ahnen, C. Richard Boland, Russell I. Heigh, David E. Fay, Elena Martinez, Elizabeth Jacobs, Erin L. Ashbeck, David S. Alberts and Peter Lance
Cancer Prev Res October 11 2012 DOI: 10.1158/1940-6207.CAPR-12-0204
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