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

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib Mesylate

About this trial

This is an interventional treatment trial for Soft Tissue and Bone Tumor

Eligibility Criteria

10 Years - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Shanghai ninth people's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib group

Arm Description

Apatinib Mesylate administered as a daily oral treatment

Outcomes

Primary Outcome Measures

Progression-free survival(PFS)

To determine 2 year PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma

Secondary Outcome Measures

Overall survival rate

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

Full Information

NCT ID

NCT03539172

First Posted

May 16, 2018

Last Updated

May 27, 2018

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03539172

Brief Title

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

Acronym

RASS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Anticipated)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib group

Arm Type

Experimental

Arm Description

Apatinib Mesylate administered as a daily oral treatment

Intervention Type

Drug

Intervention Name(s)

Apatinib Mesylate

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival(PFS)

Description

To determine 2 year PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Overall survival rate

Description

from date of enrollment until date of first death from any cause, assessed up to 2 years

Time Frame

2 year

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

Time Frame

through study completion, an average of 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shengjin Dou, MD

Phone

+8615800386875

doushengjin@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Guopei Zhu, MD

antica@gmail.com

Facility Information:

Facility Name

Shanghai ninth people's hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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