K-RAS and EGFR in Lung Cancer

Overview

Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Full Title of Study: “Genotyping K-RAS and EGFR in Greek Non-small-cell Lung Cancer Patients: Incidence, Significance and Treatment Implications”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2012

Detailed Description

A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Arms, Groups and Cohorts

  • K-RAS and EGFR mutated
  • Wild type

Clinical Trial Outcome Measures

Primary Measures

  • Progression free survival
    • Time Frame: from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 9 months
  • Overall survival
    • Time Frame: from the date of treatment start until verified disease progression, death from any cause or date of last contact whichever occurred first, up to 36 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with histologically confirmed NSCLC – Signed and dated written informed consent – Age 18 years – Available cytological material Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hellenic Cooperative Oncology Group
  • Provider of Information About this Clinical Study
    • Sponsor

References

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Citations Reporting on Results

Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.

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