NCT06836492

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
43mo left

Started Jan 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2017Dec 2029

Study Start

First participant enrolled

January 30, 2017

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 20, 2025

Status Verified

January 1, 2025

Enrollment Period

12.6 years

First QC Date

August 8, 2023

Last Update Submit

February 15, 2025

Conditions

RhabdomyosarcomaPediatric Cancer

Outcome Measures

Primary Outcomes (4)

  • The objective response rate (ORR)

    The ORR was calculated based on the best overall response.

    Up to 1 year

  • disease control rate (DCR)

    Up to 1 year

  • progression-free survival (PFS)

    Furthermore, we provided Kaplan-Meier plots for PFS

    Up to 10 years

  • overall survival (OS)

    Furthermore, we provided Kaplan-Meier plots for OS.

    Up to 10 years

Secondary Outcomes (1)

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

    Up to 10 years

Study Arms (4)

Low risk

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

Moderate risk

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

High risk

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

Very high risk

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

Interventions

VAC，VAC/VII，CAV/IECOMBINATION_PRODUCT

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

High riskLow riskModerate riskVery high risk

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Combined with immunodeficiency disease
  • Second tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suying Lu

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

RhabdomyosarcomaNeoplasms

Condition Hierarchy (Ancestors)

MyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeSarcoma

Central Study Contacts

Suying Lu

CONTACT

+020-87342460lusy@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sun Yat-sen University Cancer Center

Study Record Dates

First Submitted

August 8, 2023

First Posted

February 20, 2025

Study Start

January 30, 2017

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)