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Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00898924
First received: May 9, 2009
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
  Purpose

RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.


Condition Intervention
Lung Cancer
 Genetic: molecular diagnostic method
Genetic: mutation analysis

Study Type: Interventional
Official Title: Evaluation of EGFR and K-ras Mutations in Patients With Stage III NSCLC Treated on CALGB 30106

Resource links provided by NLM:

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

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Frequency of epidermal growth factor receptor (EGFR) and K-ras mutations [ Designated as safety issue: No ]
  • Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: November 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
  • Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.

OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.

PROJECTED ACCRUAL: A total of 49 patient specimens will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of stage III non-small cell lung cancer
  • Treated on protocol CALGB-30106

PATIENT CHARACTERISTICS:

  • Performance status 0-2

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898924

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: Pasi Janne, MD, PhD Dana-Farber Cancer Institute
  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: NCT00898924     History of Changes
Other Study ID Numbers: CDR0000491128, U10CA031946, CALGB-150508
Study First Received: May 9, 2009
Last Updated: February 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
stage IIIA non-small cell lung cancer
stage IIIB 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 June 18, 2013