Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium.

Non Small Cell Lung Cancer Clinical Trial

— HERMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260038
• Other study ID #: TOGA 1001
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: January 17, 2012
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Belgium	AZ Monica	Antwerpen
Belgium	GZA Sint Vincentius - Sint Augustinus	Antwerpen
Belgium	ZNA Middelheim - ZNA STER - ZNA Jan Palfijn	Antwerpen
Belgium	AZ St Jozef Bornem en Willebroek	Bornem
Belgium	AZ Klina	Brasschaat
Belgium	Universitair Ziekenhuis Antwerpen	Edegem	Antwerpen
Belgium	AZ St Dimpna	Geel
Belgium	AZ St Elisabeth	Herentals
Belgium	AZ Mol	Mol
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	AZ Turnhout	Turnhout

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	AstraZeneca, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	testing turn around time (in days)	how long does it take to get the mutation analysis result	up to 1 month	No
Secondary	demographics	age, gender, tumor histology, smoking history	baseline	No
Secondary	correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status		baseline	No
Secondary	correlation between family history with regards to cancer and EGFR-mutation status		baseline	No