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

Brief Title

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

Official Title

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

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 study. The treatment was radiotherapy combined with apatinib. The main
      outcome measures were ORR, DCR , OS , quality of life and drug safety. The main safety
      indicators were vital signs, laboratory indicators, adverse events (AE), and severe adverse
      events (SAE). This study is expected to be enrolled for 6 months.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate (ORR)

Secondary Outcome

 Disease Control Rate (DCR)

Condition

Childhood Rhabdomyosarcoma

Intervention

Apatinib mesylate tablets

Study Arms / Comparison Groups

 Radiotherapy plus apatinib mesylate
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

January 1, 2019

Completion Date

April 1, 2020

Primary Completion Date

April 1, 2020

Eligibility Criteria

        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:

               1. 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

               2. 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.
      

Gender

All

Ages

3 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Mawei Jiang, MD, 021-25078635, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03868852

Organization ID

XH-18-018


Responsible Party

Sponsor

Study Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine


Study Sponsor

Mawei Jiang, MD, Principal Investigator, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine


Verification Date

February 2019