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NCT00922025 Clinical Trial

Multicentre Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Male Patients

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Multi-centre, Naturalistic Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of EGFR TKI in Male Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer of Adeno Histology Failed 1st Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00922025
Other study ID # NIS-OTW-IRE-2009/1
Secondary ID
Status Completed
Phase N/A
First received June 16, 2009
Last updated September 26, 2011
Start date August 2009
Est. completion date December 2010

Study information
Verified date September 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective is to investigate the correlation between smoking pattern and clinical efficacy of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage, quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current practice of EGFR mutation testing in Taiwan will be surveyed.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Male
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Male patients age 20 years or older

- Histological or cytological confirmation of NSCLC of adeno histology. If sputum is the only available sample, a second positive test is necessary for cytological confirmation

- Locally advanced or metastatic on or after first-line chemotherapy. Imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acceptable

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Research Site Changhua
Taiwan Research Site Chiayi
Taiwan Research Site Kaohsiung
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Taipe

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between smoking patterns and best objective tumor response rate 6 Months No
Secondary correlation between smoking patterns and progression free survival (PFS) 9 months No
Secondary correlation between smoking patterns and overall survival (OS) 9 Months No
Secondary changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy 3 Months No
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