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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
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
mutation analysis
GeneticPrimary outcomes
-
Overall survival
Time frame: Up to 3 years
-
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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