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This is a non-randomized, phase II, open label study of radiotherapy concurrent with Apatinib Mesylate after surgery in patients with advanced head and neck soft tissue and bone sarcomas. The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with head and neck soft tissue and bone sarcomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib group | Experimental | Apatinib Mesylate administered as a daily oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | Apatinib Mesylate will be administered orally at 500 mg once daily from 2 weeks before the beginning of radiotherapy until the end of whole radiotherapy course |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | To determine 2 year PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | from date of enrollment until date of first death from any cause, assessed up to 2 years | 2 year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengjin Dou, MD | Contact | +8615800386875 | doushengjin@126.com | |
| Guopei Zhu, MD | Contact | antica@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
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| through study completion, an average of 2 years |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D006258 | Head and Neck Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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