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

Phase 3

Recruiting

• Conditions: Rhabdomyosarcoma; Pediatric Cancer

• Registration Number: NCT06836492
• Lead Sponsor: Yizhuo Zhang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Study First Submitted: 2023-08-08
• Status Verified: 2025-01
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2029-09
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Suying Lu; 🇨🇳 Guangzhou, Guangdong, China