Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT01211002|
Recruitment Status : Unknown
Verified September 2010 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was: Not yet recruiting
First Posted : September 29, 2010
Last Update Posted : September 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Radiation: radiotherapy combined with EP Drug: radiotherapy / EP combined with recombinant human endostatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2012|
Active Comparator: radiotherapy combined with EP
the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
Radiation: radiotherapy combined with EP
Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
Experimental: adiotherapy / EP /recombinant human endostatin
recombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection.
Drug: radiotherapy / EP combined with recombinant human endostatin
Anti-vascular targeting therapy The number of courses is 3 ~ 4 and each course last for 28 days. Recombinant human endostatin（Endostar）：15mg，d1-14, intravenous injection.
- overall survival (OS) [ Time Frame: 3 years ]
- quality of life [ Time Frame: 2 years ]
- objective response rate (ORR) [ Time Frame: 1 years ]
- disease control rate (DCR) [ Time Frame: 1 year ]
- progression-free survival (PFS) [ Time Frame: 2 years ]
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): NCT01211002
|Contact: Zhenzhou Yang, M.D.||email@example.com|
|Daping Hospital||Not yet recruiting|
|Contact: zhenzhou yang, M.D. firstname.lastname@example.org|
|Principal Investigator: zhenzhou yang, M.D.|
|Study Chair:||zhenzhou yang, M.D.||Daping Hospital and the Research Institute of Surgery of the Third Military Medical University|