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

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ClinicalTrials.gov Identifier: NCT03868852
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Childhood Rhabdomyosarcoma Drug: Apatinib mesylate tablets Radiation: Three-dimensional conformal intensity modulation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Simons two-stage design method requires the enrollment of 13 patients in the first stage. If more than 7 patients fail to reach the expected end point, the first stage fails and the patients do not need to enter the second stage. A total of 48 patients were enrolled. If more than 30 patients did not reach the expected end point, the overall trial failed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Apatinib mesylate tablets
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)

Radiation: Three-dimensional conformal intensity modulation
Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.
Other Name: 3D-IMRT




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: First analysis will occur 1 month after accrual of all patients. ]
    Refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including CR and PR cases. Objective remission of solid tumors was assessed by RECIST 1.1. Subjects must be accompanied by measurable tumor lesions at baseline. According to RECIST 1.1, the criteria for evaluating efficacy are complete remission (CR), partial remission (PR), stability (SD), and progression (PD).


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: First analysis will occur 1 month after accrual of all patients. ]
    The percentage of patients whose tumors shrink or remain stable for a certain period of time

  2. Total Survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. ]
    The time from enrollment to death for any reason. For those who had lost interviews before death, the last follow-up time was usually calculated as the time of death.

  3. Quality of Life Score [ Time Frame: Weekly assessment , assessed up to 1 month. ]

    Quality of life score refer to EORTC qlq-c30 (version 3, Chinese version). Quality of Life Questionnare-Core 30 prepared by The European O-rganization for Reasearch and Treatment of Cancer.

    EORTC qlq-c30 (V3.0) is the core scale for all cancer patients, with a total of 30 items. Items 29 and 30 are rated on a scale of 1 to 7 according to their answer choices. The other items are divided into four levels: totally not, a little bit, a lot and very much, and are scored on a scale of 1 to 4.

    The higher the score of functional domain and general health domain, the better the functional status and quality of life. The higher the score of symptom domain, the more symptoms or problems (the worse the quality of life).


  4. Incidence and severity of Adverse Events [ Time Frame: From date of enrollment until 30 days after the last medication. ]
    The safety of the drug was evaluated by NCI-CTCAE 4.0. Common Terminology Criteria Adverse Events Version 4.0 prepared by National Cancer Institute.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868852


Contacts
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Contact: Mawei Jiang, MD 021-25078635 13524527495@163.com
Contact: Chuanying Zhu, MD 13795327309 zhuchuanying@xinhuamed.com.cn

Locations
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China, Shanghai
The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Mawei Jiang, MD    02125078635    13524527495@163.com   
Principal Investigator: Mawei Jiang, MD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Mawei Jiang, MD Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03868852     History of Changes
Other Study ID Numbers: XH-18-018
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Radiation Therapy
Rhabdomyosarcoma in Children

Additional relevant MeSH terms:
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Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action