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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00008385

Run by

ECOG-ACRIN Cancer Research Group

People needed

1772

Starts

2000-12-18

Expected to finish

2019-11-01

Last updated by the study team

2023-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• North Bay Cancer Center — Fairfield, California, United States
• Rebecca and John Moores UCSD Cancer Center — La Jolla, California, United States
• Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Tibotec Therapeutics - Division of Ortho Biotech Products, LP — Marysville, California, United States
• Memorial Medical Center — Modesto, California, United States
• El Camino Hospital Cancer Center — Mountain View, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Breast Surgeons, Incorporated — Oakland, California, United States
• CCOP - Bay Area Tumor Institute — Oakland, California, United States
• Larry G Strieff MD Medical Corporation — Oakland, California, United States
• Tom K Lee, Incorporated — Oakland, California, United States
• Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States
• Valley Care Medical Center — Pleasanton, California, United States
• MBCCOP - Gulf Coast — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.