Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
Basic Trial Information
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.
Further Study Information
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.
PROJECTED ACCRUAL: A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.
PRIOR CONCURRENT THERAPY:
Trial Contact Information
Trial Lead Organizations/Sponsors
Eastern Cooperative Oncology Group
Daniel David Karp, Study Chair
Omer Kucuk, Study Chair
Randolph S. Marks, Study Chair
Michael R. Johnston, Study Chair
Gerald H. Clamon, Study Chair
Gord Okawara, Study Chair
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.