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

NCT ID: NCT06836492

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Rhabdomyosarcoma Pediatric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low risk

Group Type OTHER

VAC,VAC/VII,CAV/IE

Intervention Type COMBINATION_PRODUCT

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

Moderate risk

Group Type OTHER

VAC,VAC/VII,CAV/IE

Intervention Type COMBINATION_PRODUCT

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

High risk

Group Type OTHER

VAC,VAC/VII,CAV/IE

Intervention Type COMBINATION_PRODUCT

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

Very high risk

Group Type OTHER

VAC,VAC/VII,CAV/IE

Intervention Type COMBINATION_PRODUCT

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

Interventions

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VAC,VAC/VII,CAV/IE

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yizhuo Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yizhuo Zhang

Sun Yat-sen University Cancer Center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Suying Lu

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Suying Lu

Role: CONTACT

+020-87342460

Facility Contacts

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Suying Lu

Role: primary

+020-87342460

Other Identifiers

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SYSUCC-RMS

Identifier Type: -

Identifier Source: org_study_id

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