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:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898924
First received: May 9, 2009
Last updated: October 16, 2013
Last verified: September 2013
  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:


Further study details as provided by Alliance for Clinical Trials in Oncology:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898924

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Pasi Janne, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898924     History of Changes
Other Study ID Numbers: CDR0000491128, U10CA031946, CALGB-150508
Study First Received: May 9, 2009
Last Updated: October 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014