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Clinical Trials/NCT01260038
NCT01260038
Completed
Not Applicable

Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.

University Hospital, Antwerp11 sites in 1 country107 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non Small Cell Lung Cancer
Sponsor
University Hospital, Antwerp
Enrollment
107
Locations
11
Primary Endpoint
testing turn around time (in days)
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

This is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the routine clinical care setting in the Antwerp region (Belgium).

Detailed Description

The favourable results of a number of phase III-trials with gefitinib in NSCLC patients with activating EGFR-mutations, have resulted in the licensing of gefitinib in this indication. This offers the prospect of a true personalized treatment of patients with NSCLC. Implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the EGFR-mutation analysis and on the timely reporting of the mutation analysis results. Ideally the results should be available in all patients within 2 weeks of the analysis request.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
September 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • age 18 years or above
  • newly diagnosed NSCLC
  • written informed consent
  • tumor sample available

Exclusion Criteria

  • mixed histology of small cell and NSCLC

Outcomes

Primary Outcomes

testing turn around time (in days)

Time Frame: up to 1 month

how long does it take to get the mutation analysis result

Secondary Outcomes

  • demographics(baseline)
  • correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status(baseline)
  • correlation between family history with regards to cancer and EGFR-mutation status(baseline)

Study Sites (11)

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