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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer|
- Incidence Rate of Second Primary Lung Tumor [ Time Frame: Assessed annually for 10 years after randomization ] [ Designated as safety issue: No ]Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.
- 5-year Progression-free Survival Rate [ Time Frame: Assessed annually for 5 years after randomization ] [ Designated as safety issue: No ]
Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate.
Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.
- Different histologic type
- Location in different lobe
- Location in contralateral lung
- Occurrence > 5 years after initial diagnosis
- 5-year Overall Survival Rate [ Time Frame: Assessed annually for 5 years after randomization ] [ Designated as safety issue: No ]Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.
|Study Start Date:||October 2000|
|Estimated Study Completion Date:||November 2019|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Arm I
Participants receive an oral yeast placebo as in arm II.
Experimental: 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.
Other Name: L-selenomethionine
- 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-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.
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|