Finding studies
Finding studies
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Lead
ECOG-ACRIN Cancer Research Group
With
OBJECTIVES: Primary Objective: * 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. Secondary Objectives: * 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-blinded, 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 in a 1:2 ratio to arm I and arm II. * Arm I: Participants receive an oral yeast placebo as in arm II. * Arm II: 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. Participants are followed annually (every 12 months) for 10 years. PROJECTED ACCRUAL: A total of 1,960 participants will be accrued for this study within 4 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
