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

NCT03868852 | Unknown Phase 1 DMC

• 1 other identifier: XH-18-018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Rhabdomyosarcoma

Keywords

Radiation Therapy; Rhabdomyosarcoma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease Control Rate (DCR)

  First analysis will occur 1 month after accrual of all patients.

• Total Survival (OS)

  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.

• Quality of Life Score

  Weekly assessment , assessed up to 1 month.

• Incidence and severity of Adverse Events

  From date of enrollment until 30 days after the last medication.

Study Arms (1)

Radiotherapy plus apatinib mesylate

EXPERIMENTAL

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; Radiation: Three-dimensional conformal intensity modulation

Interventions

Apatinib mesylate tablets DRUG

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)

Radiotherapy plus apatinib mesylate

Three-dimensional conformal intensity modulation RADIATION

Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.

Also known as: 3D-IMRT

Radiotherapy plus apatinib mesylate

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 32827353 DERIVED

MeSH Terms

Interventions

apatinib

Study Officials

• Mawei Jiang, MD

  Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mawei Jiang, MD

CONTACT

021-25078635; 13524527495@163.com

Chuanying Zhu, MD

CONTACT

13795327309; zhuchuanying@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: March 11, 2019
• Study Start: January 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)