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Sponsors and Collaborators: |
Chinese Academy of Sciences Chinese Academy of Medical Sciences Shanghai Jiao Tong University of Medicine Beijing Chao Yang Hospital |
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Information provided by: | Chinese Academy of Sciences |
ClinicalTrials.gov Identifier: | NCT00576914 |
This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer.
The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: recombinant human endostatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-Center) |
Estimated Enrollment: | 1108 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
vinorelbine plus cisplatin plus recombinant human endostatin
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Drug: recombinant human endostatin
recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
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B: No Intervention
vinorelbine plus cisplatin
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Drug: recombinant human endostatin
recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
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It is an open labelled, randomized, multi-center phase III clinical trail.A total of 1108 patients with resected stage IB to stage IIIA non-small cell lung cancer will either ether the group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin randomly. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.The major inclusive criteria are pathological confirmed non-small cell lung cancer after complete resection and can tolerate chemotherapy safely.The tissue and blood samples will be banked for further investigation. All of the enrolled patients will be followed up until death or over 5 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xinling Liu, Bachelor | 86-10-87788495 | liuxinling1985@126.com |
Contact: Fang Li, M.D. | 86-13910145882 | nc_lifang@yahoo.com.cn |
China | |
The Lung Cancer Center of Cancer Hospital | Recruiting |
Beijing, China, 100021 | |
Contact: Xinling Liu, Bachelor 86-10-87788495 liuxinling1985@126.com | |
Contact: Fang Li, M.D. 86-13910145882 nc_lifang@yahoo.com.cn | |
Sub-Investigator: Xiangru Zhang, M.D. |
Study Chair: | Jie He, M.D. & Ph.D. | Cancer Hospital ,Chinese Academy of Medical Sciences |
Responsible Party: | Cancer hospital and cancer institute, Chinese academy of medical sciences ( Hejie ) |
Study ID Numbers: | 2006 BAI02A02[1]-01 |
Study First Received: | December 18, 2007 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00576914 |
Health Authority: | China: Ministry of Health |
adjuvant therapy non-small cell lung cancer vinorelbine cisplatin recombinant human endostatin(endostar) |
Thoracic Neoplasms Non-small cell lung cancer Vinorelbine Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Endostatins Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |