Phase 3
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
Bottom Line
View on ClinicalTrials.gov: NCT00706121 ↗Enrolled (actual)
8,094
Serious AEs
0.8%
Results posted
Apr 2017
Primary outcome: Primary: Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo — 1136; 1150 Participants — p=0.96
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin E (Drug); Selenium (Drug); Vitamin E placebo (Drug); selenium placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Oct 2015
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 |
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.
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). 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.