Phase 3
Completed N=8,094
S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000
Colorectal Cancer · Precancerous Condition
Source: ClinicalTrials.gov NCT00706121 ↗
Enrolled (actual)
8,094
Serious AEs
0.8%
Results posted
Apr 2017
Primary outcomePrimary: Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo — 1136; 1150 Participants — p=0.96
◆ Published Evidence
Emerging
3citations · ~0 / year
Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial.
Summary
RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.
PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.
Linked Publications
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Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo |
1136; 1150 | 0.96 |
| PRIMARY Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo |
269; 282 | 0.32 |
| PRIMARY Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence |
10; 11; 9; 6 | — |
| PRIMARY Effect of Selenium on Occurrences of Multiple (>2) Adenomas |
258; 276 | 0.24 |
| SECONDARY Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo |
1159; 1127 | 0.38 |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000
- Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial
PATIENT CHARACTERISTICS:
- Willing to sign an applicable medical records release form
- Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00706121) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.