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Sponsors and Collaborators: |
Guangdong Provincial People's Hospital Hoffmann-La Roche |
Information provided by: | Guangdong Provincial People's Hospital |
ClinicalTrials.gov Identifier: | NCT00600587 |
The purpose of this study is to evaluate the value of neoadjuvant Erlotinib therapy before thoracotomy in ⅢA-N2(confirmed by mediastinoscopy) non-small cell lung cancer(NSCLC) selected by epidermal growth factor receptor(EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.
Condition | Intervention | Phase |
Carcinoma, Non-Small-Cell Lung |
Drug: neoadjuvant erlotinib therapy Drug: neoadjuvant gemcitabine/carboplatin therapy |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Carboplatin Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Tyrosine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Phase Ⅱ Study of Neoadjuvant Erlotinib Therapy in Stage III A(N2) Non-Small Cell Lung Cancer Proceeding to Mediastinoscopy and Surgery |
Estimated Enrollment: | 46 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status:mutant-type OR high copy number OR (overexpression AND non-smokers))
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Drug: neoadjuvant erlotinib therapy
150mg erlotinib taken once daily and continued uninterrupted for 30 days before evaluation/thoracotomy.
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B: Active Comparator
Non-erlotinib targeted NSCLC population based on EGFR gene analysis
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Drug: neoadjuvant gemcitabine/carboplatin therapy
3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yi-long WU, MD | +86-020-83821484 | gzyilong2006@hotmail.com |
Contact: Xue-ning YANG, MD | +86-020-83821484 | yangxuening@gmail.com |
China, Guangdong | |||||
Guangdong Provincial People's Hospital | Recruiting | ||||
Guangzhou, Guangdong, China, 510080 | |||||
Contact: Yi-long WU, MD +86-13609777314 gzyilong2006@hotmail.com | |||||
Contact: Xue-ning YANG, MD +86-020-83827712 yangxuening@gmail.com | |||||
Principal Investigator: Yi-long WU, MD |
Guangdong Provincial People's Hospital |
Hoffmann-La Roche |
Principal Investigator: | Yi-long WU, MD | Guangdong Provincial People's Hospital |
Study Chair: | Xue-ning YANG, MD | Guangdong Provincial People's Hospital |
Study Director: | Wen-zhao ZHONG, MD | Guangdong Provincial People's Hospital |
Responsible Party: | Lung Cancer Research Institute, Guangdong Provincial People's Hospital ( Yi-long WU ) |
Study ID Numbers: | CSLC-0702, ROCHE-123456-1 |
First Received: | January 14, 2008 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00600587 |
Health Authority: | China: Ethics Committee |
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