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Phase 3 N=1,561 Randomized Triple-blind Prevention

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00008385 ↗
Enrolled (actual)
1,561
Serious AEs
1.6%
Results posted
May 2016
Primary outcome: Primary: Incidence Rate of Second Primary Lung Tumor — 1.30; 1.62 cases/100 person years — p=0.294

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
placebo (Other); selenium (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
ECOG-ACRIN Cancer Research Group
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence Rate of Second Primary Lung Tumor		 1.30; 1.62 0.294
SECONDARY
5-year Progression-free Survival Rate		 0.796; 0.744 0.069
SECONDARY
5-year Overall Survival Rate		 0.799; 0.768 0.154

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00008385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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