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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

NCT ID: NCT00922025

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Male patients with non-small cell lung cancer (NSCLC) of adeno histology

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Ming Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Ventrans General Hospital

Locations

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Research Site

Changhua, , Taiwan

Site Status

Research Site

Chiayi City, , Taiwan

Site Status

Research Site

Kaohsiung City, , Taiwan

Site Status

Research Site

Taichung, , Taiwan

Site Status

Research Site

Tainan City, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NIS-OTW-IRE-2009/1

Identifier Type: -

Identifier Source: org_study_id