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| Name | Class |
|---|---|
| Jiangsu Simcere Pharmaceutical Co., Ltd. | INDUSTRY |
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To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| concurrent chemoradiotherapy (CCRT) | Active Comparator | Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed. |
|
| W1-CCRT | Experimental | Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1). Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed. |
|
| W2-CCRT | Experimental | Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28). Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concurrent chemoradiotherapy (CCRT) | Combination Product | Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival (PFS) | Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | comparison to maintenance chemoradiotherapy alone | 4 years |
| Treatment-related toxicity | Toxicity and adverse events related to the inventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daiyuan Ma, M.D | Contact | 868172246171 | angenpn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daiyuan Ma, M.D | Affiliated Hospital of North Sichuan Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | 600000 | China |
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Patients were randomly assigned to a regimen of W1-CCRT(one treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or W2-CCRT(two treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or CCRT.
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| Endostar for one cycle | Drug | Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1). |
|
| Endostar for two cycles | Drug | Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28). |
|
| 4 years |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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