Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib
Recruitment status was Recruiting
Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.
The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.
In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.
The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.
Non-Small Cell Lung Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib|
- overall survival [ Time Frame: 1 year after the last patient is enrolled ] [ Designated as safety issue: No ]
- response( according to RECIST) [ Time Frame: 3 month after the last patient is enrolled ] [ Designated as safety issue: No ]
- quality of live ( measured by EORTC PAL 15) [ Time Frame: 3 month after the last patient is enrolled ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
a fine neddle biopsi taken when the diagnosis non-small cell lung carcinoma was made + severals blood samples taken before and during treatment with erlotinib.
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Patients with non-small cell lung cancer carcinoma treated with erlotinib
- To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
- In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
- In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815971
|Contact: Britta Weber, MDfirstname.lastname@example.org|
|Contact: Peter Meldgaard, PhD MDemail@example.com|
|department of oncology, University Hospital of Aarhus, Nørrebrogade 44||Recruiting|
|8000 Aarhus, Denmark|
|Contact: Britta Weber, MD +4589493333 firstname.lastname@example.org|
|Contact: Peter meldgaard, PhD MD +4589493333 email@example.com|
|Principal Investigator: Peter meldgaard, PhD MD|
|Principal Investigator:||Peter Meldgaard, PhD MD||Aarhus University Hospital|