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

Phase 3

Completed

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.

Recruitment & Eligibility

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:

Arm && Interventions

Group	Intervention	Description
Arm I	placebo	Participants receive an oral yeast placebo as in arm II.
Arm II	selenium	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.

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Second Primary Lung Tumor	Assessed annually for 10 years after randomization	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.

Secondary Outcome Measures

Name	Time	Method
5-year Progression-free Survival Rate	Assessed annually for 5 years after randomization	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. 1. Different histologic type 2. Location in different lobe 3. Location in contralateral lung 4. Occurrence \> 5 years after initial diagnosis
5-year Overall Survival Rate	Assessed annually for 5 years after randomization	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.

Locations (526): MBCCOP - Gulf Coast
🇺🇸
Mobile, Alabama, United States
Providence Cancer Center at Providence Hospital
🇺🇸
Mobile, Alabama, United States
Arizona Oncology Services Foundation
🇺🇸
Phoenix, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
🇺🇸
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale
🇺🇸
Scottsdale, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
🇺🇸
Scottsdale, Arizona, United States
Highlands Oncology Group - Springdale
🇺🇸
Bentonville, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
East Bay Radiation Oncology Center
🇺🇸
Castro Valley, California, United States
Eden Medical Center
🇺🇸
Castro Valley, California, United States
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MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States