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In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group | Active Comparator | paclitaxel-carboplatin |
|
| The treatment group | Experimental | paclitaxel-carboplatin plus Endostar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar(Recombinant Human Endostatin Injection) | Drug | Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | every 2 months until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | the end of each cycle | |
| Overall Survival (OS) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200039 | China |
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| paclitaxel-carboplatin | Drug | paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w |
|
| 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 |
|---|---|
| C053518 | CP protocol |
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