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
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Condition or disease |
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Non Small Cell Lung Cancer |
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 |

Group/Cohort |
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1
Male patients with non-small cell lung cancer (NSCLC) of adeno histology
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- Correlation between smoking patterns and best objective tumor response rate [ Time Frame: 6 Months ]
- 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 ]

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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 |
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

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
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 |
Principal Investigator: | Chun-Ming Tsai, MD | Taipei Ventrans General Hospital |
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 |