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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00922025
First received: June 16, 2009
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Correlation between smoking patterns and best objective tumor response rate [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between smoking patterns and progression free survival (PFS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • correlation between smoking patterns and overall survival (OS) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
  • changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Male patients with non-small cell lung cancer (NSCLC) of adeno histology

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00922025     History of Changes
Other Study ID Numbers: NIS-OTW-IRE-2009/1
Study First Received: June 16, 2009
Last Updated: September 26, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by AstraZeneca:
NSCLC
Male
Smoking Pattern
Efficacy

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

ClinicalTrials.gov processed this record on May 19, 2013