Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: placebo
* Drug: selenium


Participation Criteria
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Eligibility Criteria
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RUN-IN PERIOD: Inclusion Criteria: Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)* Completion of treatment for stage I lung cancer within the past 6 to 36 months and currently disease free At least one mediastinal lymph node sampled at resection NOTE: *Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (CALGB) patients must be T1, N0; CALGB patients may be T2, N0 provided disease was completely resected prior to June 1, 2001 and participation in CALGB 9633 was refused if offered 18 years old and over Eastern Cooperative Oncology Group performance status 0-1 Bilirubin no greater than upper limit of normal (ULN) Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN Prior mineral, herbal, phytochemical, or vitamin supplementation allowed Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged Exclusion Criteria: Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks Synchronous lung or non-lung lesions or metastasis, even if resectable History of more than one primary lung cancer at any time Concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer Prior or concurrent chemotherapy for recurrent lung cancer Prior or concurrent radiotherapy for recurrent lung cancer Concurrent surgery Concurrent supplement(s) containing more than 50 micrograms of selenium STUDY PHASE: Free of disease Consumed at least 75% of tablets during 4-week run-in period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm I<br>Participants receive an oral yeast placebo as in arm II. | Other: placebo<br>* Given orally<br>|
| Experimental: Arm II<br>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. | Drug: selenium<br>* Given orally<br>* Other names: L-selenomethionine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Second Primary Lung Tumor | 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. | Assessed annually for 10 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year Progression-free Survival Rate | 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 | Assessed annually for 5 years after randomization | 
| 5-year Overall Survival Rate | 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. | Assessed annually for 5 years after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer