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| Name | Class |
|---|---|
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
| Shanghai Chest Hospital | OTHER |
| Simcere Pharmaceutical Co., Ltd | OTHER |
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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.
It is an open labelled, randomized, mono-center phase III clinical trail.A total of 250 patients with resected stage IB to stage IIIA non-small cell lung cancer will either 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP plus recombinant human endostatin | Experimental |
| |
| vinorelbine plus cisplatin | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human endostatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | five years |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival(DFS) | five years | |
| the toxicity and safety | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liao Meilin, M.D. | Shanghai Chest Hospital | Study Chair |
| Lu sun, M.D. | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Lung Cancer Center of shanghai chest Hospital | Shanghai | 2000043 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22537906 | Derived | Zhou Z, Chen ZW, Yang XH, Shen L, Ai XH, Lu S, Luo QQ. Establishment of a biomarker model for predicting bone metastasis in resected stage III non-small cell lung cancer. J Exp Clin Cancer Res. 2012 Apr 26;31(1):34. doi: 10.1186/1756-9966-31-34. |
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|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
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