NCT00706121

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,094

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

7.3 years

First QC Date

June 26, 2008

Results QC Date

February 15, 2017

Last Update Submit

December 6, 2019

Conditions

Colorectal CancerPrecancerous Condition

Keywords

colon cancerrectal canceradenomatous polyp

Outcome Measures

Primary Outcomes (4)

  • Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

    From 1 year post randomization through study completion

  • Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo

    Adenomas with diameter \>=1cm or any adenoma with villous features or high-grade dysplasia

    From 1 year post randomization through study completion

  • Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence

    From 1 year post randomization through study completion

  • Effect of Selenium on Occurrences of Multiple (>2) Adenomas

    From 1 year post randomization through study completion

Secondary Outcomes (1)

  • Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo

    From 1 year post randomization through study completion

Other Outcomes (4)

  • Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

    From 1 year post randomization through study completion

  • Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

    From 1 year post randomization through study completion

  • Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo

    From 1 year post randomization through study completion

  • +1 more other outcomes

Study Arms (4)

Vitamin E + selenium placebo

EXPERIMENTAL

Vitamin E and selenium placebo daily for 7 - 12 years

Drug: Vitamin EDrug: selenium placebo

Selenium + vitamin E placebo

EXPERIMENTAL

Selenium and vitamin E placebo daily for 7 - 12 years

Drug: SeleniumDrug: Vitamin E placebo

Vitamin E + selenium

EXPERIMENTAL

Vitamin E and selenium daily for 7 - 12 years

Drug: Vitamin EDrug: Selenium

Vitamin E placebo + selenium placebo

PLACEBO COMPARATOR

Vitamin E placebo and selenium placebo daily for 7 - 12 years

Drug: Vitamin E placeboDrug: selenium placebo

Interventions

Vitamin EDRUG

400 IU daily by mouth for 7 - 12 years

Also known as: alpha tocopherol
Vitamin E + seleniumVitamin E + selenium placebo
SeleniumDRUG

200 mcg daily for 7 - 12 years

Also known as: L-selenomethionine
Selenium + vitamin E placeboVitamin E + selenium
Vitamin E placeboDRUG

1 pill by mouth daily for 7 - 12 years

Also known as: placebo
Selenium + vitamin E placeboVitamin E placebo + selenium placebo
selenium placeboDRUG

1 pill by mouth daily for 7 - 12 years

Also known as: placebo
Vitamin E + selenium placeboVitamin E placebo + selenium placebo

Eligibility Criteria

Age50 Years - 120 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 86724, United States

Location

Related Publications (1)

  • Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.

    PMID: 27519183DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsPrecancerous ConditionsColonic NeoplasmsRectal NeoplasmsAdenomatous Polyps

Interventions

Vitamin Ealpha-TocopherolSelenium

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTocopherolsChalcogensElementsInorganic ChemicalsMinerals

Results Point of Contact

Title
SELECT/S0000D Statistician
Organization
SWOG Statistical Center
206-667-4623

Study Officials

  • M. Peter Lance, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 27, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2015

Study Completion

January 1, 2018

Last Updated

December 16, 2019

Results First Posted

April 4, 2017

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

http://swog.org/Visitors/Download/Policies/Policy43.pdf

Locations

US(1)