Menu
Recruiting NCT06836492

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

Phase III Interventional Rhabdomyosarcoma Pediatric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VAC，VAC/VII，CAV/IE.
Who it may be relevant to
Registry conditions: Rhabdomyosarcoma, Pediatric Cancer. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Combination product VAC，VAC/VII，CAV/IE
    Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP

Primary outcome measures

  • The objective response rate (ORR) [Time frame: Up to 1 year]
  • disease control rate (DCR) [Time frame: Up to 1 year]
  • progression-free survival (PFS) [Time frame: Up to 10 years]
  • overall survival (OS) [Time frame: Up to 10 years]
Secondary outcome measures (1)
  • The safety of the SYSUCC-RMS regimen for pediatric RMS patients. [Time frame: Up to 10 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Combined with immunodeficiency disease
  • Second tumor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Suying Lu — Guangzhou

Identifiers

NCT: NCT06836492 · SYSUCC-RMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗