NCT03539172

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

May 16, 2018

Last Update Submit

May 27, 2018

Conditions

Soft Tissue and Bone TumorHead and Neck CancerSarcoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival rate

    2 year

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

    through study completion, an average of 2 years

Study Arms (1)

Apatinib group

EXPERIMENTAL

Apatinib Mesylate administered as a daily oral treatment

Drug: Apatinib Mesylate

Interventions

Apatinib MesylateDRUG

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

Apatinib group

Eligibility Criteria

Age10 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Neoplasms, Connective and Soft TissueHead and Neck NeoplasmsSarcoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Central Study Contacts

Shengjin Dou, MD

CONTACT

+8615800386875doushengjin@126.com

Guopei Zhu, MD

CONTACT

antica@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 29, 2018

Study Start

June 1, 2018

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

CN(1)