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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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00922025
First received: June 16, 2009
Last updated: September 26, 2011
Last verified: September 2011
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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:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Correlation between smoking patterns and best objective tumor response rate [ Time Frame: 6 Months ]
Secondary Outcome Measures:
- correlation between smoking patterns and progression free survival (PFS) [ Time Frame: 9 months ]
- correlation between smoking patterns and overall survival (OS) [ Time Frame: 9 Months ]
- changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy [ Time Frame: 3 Months ]
| 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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922025
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
| 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 |
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 |
ClinicalTrials.gov processed this record on July 21, 2017