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

NCT ID: NCT03539172

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-03-01

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.

Conditions

Soft Tissue and Bone Tumor; Head and Neck Cancer; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib group

Apatinib Mesylate administered as a daily oral treatment

Group Type: EXPERIMENTAL

Apatinib Mesylate

Intervention Type: 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

Interventions

Apatinib 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Shengjin Dou, MD

Role: CONTACT

doushengjin@126.com

+8615800386875

Guopei Zhu, MD

Role: CONTACT

antica@gmail.com

Other Identifiers

2018HNRT01

Identifier Type: -

Identifier Source: org_study_id