Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1772
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants receive an oral yeast placebo as in arm II. arm 2: 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.

Interventions: intervention 1: placebo intervention 2: selenium
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol document: