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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:
ClinicalTrials.gov Identifier:
NCT00898924
First Posted: May 12, 2009
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
May 9, 2009
May 12, 2009
June 29, 2016
November 2005
March 2006   (Final data collection date for primary outcome measure)
  • Overall survival [ Time Frame: Up to 3 years ]
  • Progression free survival [ Time Frame: Up to 3 years ]
  • Frequency of epidermal growth factor receptor (EGFR) and K-ras mutations
  • Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment
Complete list of historical versions of study NCT00898924 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer
Evaluation of EGFR and K-ras Mutations in Patients With Stage III NSCLC Treated on CALGB 30106

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
tissue, whole blood and serum samples
Non-Probability Sample
Patients diagnosed with stage III non-small cell lung cancer.
Lung Cancer
  • Genetic: molecular diagnostic method
  • Genetic: mutation analysis
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.
Interventions:
  • Genetic: molecular diagnostic method
  • Genetic: mutation analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2010
March 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00898924
CALGB-150508
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-150508
CDR0000491128 ( Registry Identifier: NCI Physician Data Query )
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Pasi Janne, MD, PhD Dana-Farber Cancer Institute
Alliance for Clinical Trials in Oncology
June 2016