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Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01294280
First received: February 10, 2011
Last updated: February 12, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Lung Cancer
 Genetic: mutation analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prognostic values [ Designated as safety issue: No ]
  • Predictive markers [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 1606
Study Start Date: August 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of early-stage non-small cell lung cancer

  • Specimens must be from 1 of the following studies:

    • CALGB9633
    • FRE-ALT
    • CAN-NCIC-BR10
    • Adjuvant Navelbine International Trialist Association (ANITA)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294280

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: Stephen L. Graziano, MD State University of New York - Upstate Medical University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01294280     History of Changes
Other Study ID Numbers: CDR0000600208, CALGB-150802
Study First Received: February 10, 2011
Last Updated: February 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer
stage IIA non-small cell lung cancer
stage IIB non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013