Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: placebo; selenium
Intervention description: Given orally; Given orally
Intervention MeSH terms: Selenium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1772.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer

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.
    

Eligibility 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