K-RAS and EGFR in Lung Cancer

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT03951233
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

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

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).

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2012-12
• Study Completion: 2014-12
• Status Verified: 2019-05
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-15
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival	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	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

Trial Locations

Locations (1)

Oncology Unit, Metropolitan Hospital; 🇬🇷 Néo Fáliro, Athens, Greece