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| Descriptive Information Fields | |||||
| Brief Title † | Selenium in Treating Patients With Adenomatous Colorectal Polyps | ||||
| Official Title † | Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence | ||||
| Brief Summary | 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. |
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| Detailed Description | 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 1,600 patients will be accrued for this study. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | Recurrence rate and size of colorectal polyps reduction as measured by colonoscopy after 3-5 year of study treatment [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Tolerance and adequate adherence to long term selenium treatment as measured by adverse events, serious adverse events, and laboratory values every 3-4 months during treatment, and 1 month after study completion [ Designated as safety issue: Yes ] | ||||
| Condition † | Colorectal Cancer | ||||
| Intervention † | Drug: placebo Drug: selenium |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() Featured trial article  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 1850 | ||||
| Start Date † | January 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00078897 | ||||
| Organization ID | CDR0000353185 | ||||
| Secondary IDs †† | UARIZ-00-0430-01, UARIZ-HSC-00142 | ||||
| Study Sponsor † | University of Arizona | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | March 8, 2004 | ||||
| Last Updated Date | July 23, 2008 | ||||