Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
RATIONALE: Studying samples of tissue in the laboratory from patients undergoing adjuvant chemotherapy may help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in predicting response in patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy.
Genetic: mutation analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: medical chart review
|Official Title:||Participation in the Lung Adjuvant Cisplatin Evaluation Biological Program (LACE-BIO). A Study of Prognostic and Predictive Markers in Early Stage Non-Small Cell Lung Cancer|
- Prognostic values [ Designated as safety issue: No ]
- Predictive markers [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- To evaluate potential prognostic and predictive markers in patients treated with adjuvant chemotherapy for early-stage non-small cell lung cancer.
- To perform cross-validation analyses for the predictive value of p27, ERCC1, and beta-tubulin.
- To perform cross-validation analyses for the prognostic value of mucin and BRCA1 expression.
- To perform a pooled analysis for the prognostic impact of p53 protein expression by IHC, p53 mutation, ras mutation, and EGFR mutation.
OUTLINE: This is a multicenter study. Patients are stratified according to planned radiotherapy (yes vs no), area of the world (Eastern Europe vs Western Europe vs rest of the world), and center size (< 20 vs > 20 patients).
Tumor tissue samples are selected from CALGB-9633 and from Lung Adjuvant Cisplatin Evaluation (LACE) group's studies; ANITA, FRE-IALT, and CAN-NCIC-BR10. Clinical data are gathered from these patients' protocol records and sent to Institute Gustave-Roussy for cross-validation studies and pooled analyses.
Tissue samples are analyzed by IHC to identify predictive markers and investigate protein expression and mutations and by Cox model for prognostic values.
|Study Chair:||Stephen L. Graziano, MD||State University of New York - Upstate Medical University|