Radiotherapy Concurrent With Apatinib in Advanced Soft Tissue and Bone Sarcomas of Head and Neck--RASS Study

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial of Radiotherapy Concurrent With Apatinib in Advanced Soft Tissue and Bone Sarcomas of Head and Neck: the RASS Study

Conditions
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Sarcoma, Soft Tissue and Bone Tumor, Head and Neck Cancer

Intervention / Treatment
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* Drug: Apatinib Mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of head and neck soft tissue sarcoma (undifferentiated pleomorphic sarcoma, synovial sarcoma, alveolar soft part sarcoma, clear cell sarcoma, angiosarcoma, epithelioid hemangiosarcoma, solitary fibrous tumor and epithelioid sarcomas) or bone sarcoma (osteosarcoma/high grade bone sarcoma, Ewing sarcoma or dedifferentiated chondrosarcoma) confirmed by central pathology review. Gross total resection, with Invasive cancer seen on microscopic evaluation of the resection margin, or with gross tumor residual, or surgically unresectable and/or refuse surgery. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Adequate hepatic, renal, cardiac, and hematologic function. Patients must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Exclusion Criteria: Evidence of distant metastasis Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50% Patients who have had prior allergic reaction to Apatinib

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib group<br>Apatinib Mesylate administered as a daily oral treatment | Drug: Apatinib Mesylate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | through study completion, an average of 2 years |