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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
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The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).
To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGP group | Experimental | the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy |
|
| GP group | Active Comparator | the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Endostatin plus gemcitabine and cisplatin | Drug | target therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival(PFS) | PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups. | 2years after the inception assignment |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups. | 1 year ,2 years and 3 years after the inception of the assignment |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of life assessment | According to the most commonly used questionnaire EORTC QLQ C30 and H&N35 35 for evaluation | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 6 months thereafter for 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaozhong Chen | Contact | 86-571-88122098 | cxzfyun@sina.com | |
| Bin Li | Contact | 86-571-88122091 | libindoctor@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaozhong Chen | Zhejiang Cancer Hospital | Principal Investigator |
| Xiaozhong Chen | Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
|
| Gemcitabine and cisplatin | Drug | only chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks. |
|
|
| Adverse events |
observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up. |
| participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| 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 |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |