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

Childhood Rhabdomyosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868852
• Other study ID #: XH-18-018
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Mawei Jiang, MD
• Phone: 021-25078635
• Email: 13524527495[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Rhabdomyosarcoma
• Rhabdomyosarcoma

Intervention

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.

Locations

Country	Name	City	State
China	The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	First analysis will occur 1 month after accrual of all patients.
Secondary	Disease Control Rate (DCR)	The percentage of patients whose tumors shrink or remain stable for a certain period of time	First analysis will occur 1 month after accrual of all patients.
Secondary	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.	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.
Secondary	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).	Weekly assessment , assessed up to 1 month.
Secondary	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.	From date of enrollment until 30 days after the last medication.