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

ECOG-ACRIN Cancer Research Group

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Drug: selenium; Other: placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00008385

E5597 (Other Identifier)

U10CA023318 (U.S. NIH Grant/Contract)

CDR0000068402 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,772 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,772 participants in 2 patient groups, including a placebo group

Arm I

Placebo Comparator group

Description:

Participants receive an oral yeast placebo as in arm II.

Treatment:

Other: placebo

Arm II

Experimental group

Description:

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.

Treatment:

Drug: selenium