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OpenTrials
Completed

NCT Number: NCT00898924

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

molecular diagnostic method

Genetic

mutation analysis

Genetic

Primary outcomes

  1. Overall survival

    Time frame: Up to 3 years

  2. Progression free survival

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of EGFR and K-ras Mutations in Patients With Stage III NSCLC Treated on CALGB 30106

Important dates

Study start
2005
Primary completion
2006
Study completion
2010
First posted
May 12, 2009
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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