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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00922025

Enrollment

186

Registered

2009-06-17

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC, Male, Smoking Pattern, Efficacy

Brief 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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Correlation between smoking patterns and best objective tumor response rate	6 Months

Secondary

Measure	Time frame
correlation between smoking patterns and progression free survival (PFS)	9 months
correlation between smoking patterns and overall survival (OS)	9 Months
changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy	3 Months

Countries

Taiwan

Outcome results