A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors.

A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.

The purpose is to explore the efficacy and safety of the SYSUCC-RMS regimen for pediatric RMS patients and to explore the impact of concurrent radiotherapy and chemotherapy on the survival rate of low-risk, medium risk, high-risk, and extremely high-risk patients in children.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer; Rhabdomyosarcoma
• Intervention / Treatment: Combination product: VAC，VAC/VII，CAV/IE

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Suying Lu; Phone Number: +020-87342460; Email: lusy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Suying Lu
      • Contact: Suying Lu; Phone Number: +020-87342460; Email: lusy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 0 years < age < 18 years old, regardless of gender;
2. Tumor patients diagnosed by histopathology or bone marrow cytology;
3. Patients are treated for the first time;
4. ECoG score ≤ 2;
5. The expected survival time is more than 8 months;
6. Patient's parent or guardian signs informed consent.

Exclusion Criteria:

1. Combined with immunodeficiency disease
2. Second tumor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Low risk	Combination product: VAC，VAC/VII，CAV/IE; Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP
Other: Moderate risk	Combination product: VAC，VAC/VII，CAV/IE; Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP
Other: High risk	Combination product: VAC，VAC/VII，CAV/IE; Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP
Other: Very high risk	Combination product: VAC，VAC/VII，CAV/IE; Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The objective response rate (ORR)	The ORR was calculated based on the best overall response.	Up to 1 year
disease control rate (DCR)		Up to 1 year
progression-free survival (PFS)	Furthermore, we provided Kaplan-Meier plots for PFS	Up to 10 years
overall survival (OS)	Furthermore, we provided Kaplan-Meier plots for OS.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of the SYSUCC-RMS regimen for pediatric RMS patients.	Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0.	Up to 10 years

Collaborators and Investigators

• Sponsor: Yizhuo Zhang

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Rhabdomyosarcoma
• Other Study ID Numbers: SYSUCC-RMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No