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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00078897 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
Condition | Intervention | Phase |
Colorectal Cancer Precancerous/Nonmalignant Condition |
Drug: placebo Drug: selenium |
Phase III |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Drug Information available for: | Selenium |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence |
Estimated Enrollment: | 2050 |
Study Start Date: | January 2001 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive oral selenium once daily.
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Drug: selenium
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo once daily.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to use of low-dose (≤ 81 mg/day) aspirin (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients undergo follow-up colonoscopy periodically for approximately 5 years* after baseline colonoscopy.
NOTE: Some patients will continue participation for up to 7.6 years
PROJECTED ACCRUAL: A total of 1,850 patients will be accrued for this study followed by a second accrual of 200 patients with advanced adenoma for a substudy.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets the following criteria by colonoscopy (performed within the past 6 months):
No prior diagnosis of any of the following:
Hereditary non-polyposis colon cancer (HNPCC), defined as:
Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No poorly controlled diabetes mellitus despite medication, defined as:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |||||
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting | ||||
Tucson, Arizona, United States, 85724-5024 | |||||
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |||||
Mayo Clinic Scottsdale | Recruiting | ||||
Scottsdale, Arizona, United States, 85259-5499 | |||||
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |||||
Veterans Affairs Medical Center - Phoenix | Recruiting | ||||
Phoenix, Arizona, United States, 85012 | |||||
Contact: Francisco Ramirez, MD 602-264-4461 | |||||
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Recruiting | ||||
Scottsdale, Arizona, United States, 85258-4512 | |||||
Contact: Liane Fales, RN 602-264-4461 lfales@email.arizona.edu | |||||
United States, Colorado | |||||
University of Colorado Cancer Center at UC Health Sciences Center | Recruiting | ||||
Aurora, Colorado, United States, 80045 | |||||
Contact: Dennis J. Ahnen, MD 303-399-8020 x3018 | |||||
United States, Texas | |||||
Baylor University Medical Center - Dallas | Recruiting | ||||
Dallas, Texas, United States, 75246 | |||||
Contact: Clinical Trials Office - Baylor University Medical Center - Da 800-422-9567 |
University of Arizona |
National Cancer Institute (NCI) |
Principal Investigator: | M. Peter Lance, MD | University of Arizona |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Featured trial article 
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Study ID Numbers: | CDR0000353185, UARIZ-00-0430-01, UARIZ-HSC-00142 |
First Received: | March 8, 2004 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00078897 |
Health Authority: | Unspecified |
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