Head and Neck Cancer, Sarcoma, Soft Tissue and Bone Tumor
Conditions
Brief summary
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.
Interventions
DRUGApatinib Mesylate
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
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
10 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 4. Adequate hepatic, renal, cardiac, and hematologic function. 5. 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
1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. 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 6. 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% 7. Patients who have had prior allergic reaction to Apatinib
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | 2 year | To determine 2 year PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 2 year | from date of enrollment until date of first death from any cause, assessed up to 2 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 | through study completion, an average of 2 years | — |
Countries
China
Contacts
Primary ContactShengjin Dou, MD
Backup ContactGuopei Zhu, MD
Outcome results
None listed