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

Yizhuo Zhang

Status and phase: Enrolling; Phase 3

Conditions: Rhabdomyosarcoma; Pediatric Cancer

Treatments: Combination Product: VAC，VAC/VII，CAV/IE

Study type: Interventional

Funder types: Other

Identifiers

NCT06836492

SYSUCC-RMS

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Low risk

Other group

Treatment:

Combination Product: VAC，VAC/VII，CAV/IE

Moderate risk

Other group

Treatment:

Combination Product: VAC，VAC/VII，CAV/IE

High risk

Other group

Treatment:

Combination Product: VAC，VAC/VII，CAV/IE

Very high risk

Other group

Treatment:

Combination Product: VAC，VAC/VII，CAV/IE