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
1 other identifier
observational
186
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedSeptember 27, 2011
September 1, 2011
1.3 years
June 16, 2009
September 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between smoking patterns and best objective tumor response rate
6 Months
Secondary Outcomes (3)
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
Study Arms (1)
1
Male patients with non-small cell lung cancer (NSCLC) of adeno histology
Eligibility Criteria
Primary Care Clinic
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Changhua, Taiwan
Research Site
Chiayi City, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chun-Ming Tsai, MD
Taipei Ventrans General Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
September 27, 2011
Record last verified: 2011-09