Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
Recruitment status was Active, not recruiting
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294280
|Study Chair:||Stephen L. Graziano, MD||State University of New York - Upstate Medical University|