Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT03868852
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Childhood Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib mesylate tablets — DRUG
    Apatinib mesylate tablets were orally administered 250 mg QD from 1 week before radiotherapy to the whole radiotherapy period. (Appatinib is no longer used after radiotherapy)
  • Three-dimensional conformal intensity modulation — RADIATION
    Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.

Study Details

The purpose of this study is to evaluate the efficacy and safety of radiotherapy combined with apatinib mesylate in the treatment of rhabdomyosarcoma in children.

Key Dates

Start date
Jan 1, 2019
Status verified
Feb 2019
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020

Study Design

Enrollment
48 participants (estimated)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy plus apatinib mesylate
    All eligible patients signed informed consent. Three-dimensional conformal intensity modulation (IMRT) technique was used to treat the patients with radiation doses 45 Gy - 54 Gy. All patients took apatinib mesylate tablets 250 mg QD orally from 1 week before radiotherapy to the whole radiotherapy period. They were required to take apatinib mesylate tablets with warm boiling water half an hour after meal. The daily medication time should be as consistent as possible.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: First analysis will occur 1 month after accrual of all patients. ]

Central Contacts

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