Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if selenium is effective in preventing the growth of new tumors in patients with previously resected non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared to a placebo in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer|
- Incidence second of primary lung tumors [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Incidence of specific cancers, mortality from cancer, and overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
Dietary Supplement: selenium
Placebo Comparator: Arm II
Participants receive an oral yeast placebo as in arm I.
- Determine the efficacy of selenium in terms of reducing the incidence of second primary lung tumors in participants with previously resected stage I non-small cell lung cancer.
- Evaluate the qualitative and quantitative toxicity of selenium in these patients.
- Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to smoking status (actively smoking or stopped less than 1 year ago vs stopped at least 1 year ago vs never smoked or no more than 100 cigarettes ever), gender, and stage and previous therapy (stage IA vs stage IB with previous therapy vs. stage IB with no previous therapy). Participants are randomized to one of two arms.
- Arm I: Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
- Arm II: Participants receive an oral yeast placebo as in arm I. Participants are followed annually.
PROJECTED ACCRUAL: A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008385
Show 532 Study Locations
|Study Chair:||Daniel D. Karp, MD||M.D. Anderson Cancer Center|
|Study Chair:||Omer Kucuk, MD||Barbara Ann Karmanos Cancer Institute|
|Study Chair:||Randolph S. Marks, MD||Mayo Clinic|
|Study Chair:||Michael R. Johnston, MD, FRCSC||Nova Scotia Cancer Centre|
|Study Chair:||Gerald H. Clamon, MD||Holden Comprehensive Cancer Center|
|Study Chair:||Gord Okawara, MD||Margaret and Charles Juravinski Cancer Centre|