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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

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ClinicalTrials.gov Identifier: NCT00922025
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : September 27, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Non Small Cell Lung Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 186 participants
Time Perspective: Prospective
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
Study Start Date : August 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Smoking
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1
Male patients with non-small cell lung cancer (NSCLC) of adeno histology


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Correlation between smoking patterns and best objective tumor response rate [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. correlation between smoking patterns and progression free survival (PFS) [ Time Frame: 9 months ]
  2. correlation between smoking patterns and overall survival (OS) [ Time Frame: 9 Months ]
  3. changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy [ Time Frame: 3 Months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922025


Locations
Taiwan
Research Site
Changhua, Taiwan
Research Site
Chiayi, Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipe, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Chun-Ming Tsai, MD Taipei Ventrans General Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00922025     History of Changes
Other Study ID Numbers: NIS-OTW-IRE-2009/1
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by AstraZeneca:
NSCLC
Male
Smoking Pattern
Efficacy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms