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

Primary Purpose

Childhood Rhabdomyosarcoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Apatinib mesylate tablets
Three-dimensional conformal intensity modulation
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Rhabdomyosarcoma focused on measuring Radiation Therapy, Rhabdomyosarcoma in Children

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy plus apatinib mesylate

Arm 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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
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

Disease Control Rate (DCR)
The percentage of patients whose tumors shrink or remain stable for a certain period of time
Total Survival (OS)
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.
Quality of Life Score
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).
Incidence and severity of Adverse Events
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.

Full Information

First Posted
February 11, 2019
Last Updated
March 7, 2019
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03868852
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Rhabdomyosarcoma
Keywords
Radiation Therapy, Rhabdomyosarcoma in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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)
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy plus apatinib mesylate
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Apatinib mesylate tablets
Intervention Description
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)
Intervention Type
Radiation
Intervention Name(s)
Three-dimensional conformal intensity modulation
Other Intervention Name(s)
3D-IMRT
Intervention Description
Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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).
Time Frame
First analysis will occur 1 month after accrual of all patients.
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
The percentage of patients whose tumors shrink or remain stable for a certain period of time
Time Frame
First analysis will occur 1 month after accrual of all patients.
Title
Total Survival (OS)
Description
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.
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.
Title
Quality of Life Score
Description
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).
Time Frame
Weekly assessment , assessed up to 1 month.
Title
Incidence and severity of Adverse Events
Description
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.
Time Frame
From date of enrollment until 30 days after the last medication.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mawei Jiang, MD
Phone
021-25078635
Email
13524527495@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanying Zhu, MD
Phone
13795327309
Email
zhuchuanying@xinhuamed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mawei Jiang, MD
Organizational Affiliation
Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mawei Jiang, MD
Phone
02125078635
Email
13524527495@163.com
First Name & Middle Initial & Last Name & Degree
Mawei Jiang, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32827353
Citation
Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
Results Reference
derived

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

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