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Selenium Chemoprevention in Resected Stage I NSCLC
NCT00008385Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2000
- Primary completion
- Jun 2011
- Countries
- 2
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Modality
- Orthosteric Ligands
- Drugs
- selenium
- Conditions
- lung cancer
01
Overview
Phase 3, randomised, double-blind trial in lung cancer comparing Placebo with Selenium (2 arms). Primary endpoint: Incidence Rate of Second Primary Lung Tumor at 10 years. Started Dec 2000; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Oral yeast placebo daily
Selenium
Oral selenium yeast daily
03
Who it enrols
Patients with histologically confirmed, completely resected stage IA or IB non-small cell lung cancer who are currently disease-free and completed treatment 6-36 months ago.
04
Endpoints
Primary
Incidence Rate of Second Primary Lung Tumor
Secondary
5-year Progression-free Survival Rate
5-year Overall Survival Rate
Qualitative and Quantitative Toxicity
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