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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 (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898924
First received: May 9, 2009
Last updated: June 28, 2016
Last verified: June 2016
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
tissue, whole blood and serum samples

Enrollment: 60
Study Start Date: November 2005
Study Completion Date: July 2010
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Tissue samples were collected from patients on Day 1, Cycle 1. Whole blood and serum samples were collected on Day 1 (Cycle 1), Day 1 (Cycle 3), post-radiotherapy ZD1839 and at progression.
Genetic: molecular diagnostic method Genetic: mutation analysis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with stage III non-small cell lung cancer.
Criteria

Inclusion criteria:

  1. Eligible patients had histologic documentation of un- treated stage III NSCLC.
  2. Radiation oncologist confirmation was required that radiation could be given per protocol.
  3. Eastern Cooperative Group Criteria Performance Status of 0 to 2
  4. Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
  5. Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines

Exclusion criteria:

1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.

  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
National Cancer Institute (NCI)
Investigators
Study Chair: Pasi Janne, MD, PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898924     History of Changes
Other Study ID Numbers: CALGB-150508  U10CA031946  CDR0000491128 
Study First Received: May 9, 2009
Last Updated: June 28, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016