Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

• 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-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.

• Arm I: 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.

• Arm II: Participants receive an oral yeast placebo as in arm I. Participants are followed annually.

PROJECTED ACCRUAL: A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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: *SWOG and 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

• No evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks

• No synchronous lung or non-lung lesions or metastasis, even if resectable

• No history of more than one primary lung cancer at any time

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT or SGPT no greater than ULN

Renal:

• Not specified

Other:

• No concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior or concurrent chemotherapy for recurrent lung cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior or concurrent radiotherapy for recurrent lung cancer

Surgery:

• See Disease Characteristics

• No concurrent surgery

Other:

• Prior mineral, herbal, phytochemical, or vitamin supplementation allowed

• No concurrent supplement(s) containing more than 50 micrograms of selenium

• Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged

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.
NLM Identifer NCT00008385
Information obtained from ClinicalTrials.gov on December 03, 2012

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