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Status:

UNKNOWN

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

Lead Sponsor:

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Conditions:

Childhood Rhabdomyosarcoma

Eligibility:

All Genders

3-18 years

Phase:

PHASE1

PHASE2

Brief Summary

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.

Detailed Description

This study is a Interventional study. The target group was 3-18 years old, and the pathological stage was group II-IV recurrence or distant metastasis. A total of 48 patients were enrolled in this stu...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patients must be ≥ 3 and ≤ 18 years of age.
  • The predicted survival period is more than 3 months.
  • According to RECIST version 1.1, there is at least one measurable lesion.
  • Postoperative pathological stage was group II-IV.
  • Patients have not received radiotherapy before, and can accept chemotherapy and surgical treatment.
  • No other anticancer therapy should be used during radiotherapy.
  • The main organs are functioning normally, which meets the following criteria:
  • Blood routine examination standards should be met: (no blood transfusion within 14 days) A.HB\>90g/L; B.ANC\>1.5\*109/L; C.PLT\>80\*109/L
  • Biochemical tests should meet the following criteria:
  • A. BIL \< 1.25 times normal upper limit (ULN); B. ALT and AST \< 2.5 ULN; C. Serum Cr \< 1 ULN, endogenous creatinine clearance \> 50 ml/min
  • Subjects volunteered to participate in this study, patients or legal guardians signed informed consent through patient consent, good compliance, with follow-up.
  • Doctors believe that treatment can benefit patients.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 1 2020

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT03868852

    Start Date

    January 1 2019

    End Date

    April 1 2020

    Last Update

    March 11 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China, 200092