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NCT Number: NCT06836492

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

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.

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Key information

Conditions

Rhabdomyosarcoma Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pediatric Cancer Sarcoma

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VAC，VAC/VII，CAV/IE

Combination Product

Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP

Primary outcomes

  1. The objective response rate (ORR)

    Time frame: Up to 1 year

    The ORR was calculated based on the best overall response.

  2. disease control rate (DCR)

    Time frame: Up to 1 year

  3. progression-free survival (PFS)

    Time frame: Up to 10 years

    Furthermore, we provided Kaplan-Meier plots for PFS

  4. overall survival (OS)

    Time frame: Up to 10 years

    Furthermore, we provided Kaplan-Meier plots for OS.

Secondary outcomes

  1. The safety of the SYSUCC-RMS regimen for pediatric RMS patients.

    Time frame: Up to 10 years

    Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Suying Lu

CONTACT

[email protected]

+020-87342460

Sponsors and collaborators

Lead sponsor

Yizhuo Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2029
Study completion
2029
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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