Pediatric Cancer, Rhabdomyosarcoma
Conditions
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.
Interventions
COMBINATION_PRODUCTVAC，VAC/VII，CAV/IE
Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP
Sponsors
Yizhuo Zhang
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The objective response rate (ORR) | Up to 1 year | The ORR was calculated based on the best overall response. |
| disease control rate (DCR) | Up to 1 year | — |
| progression-free survival (PFS) | Up to 10 years | Furthermore, we provided Kaplan-Meier plots for PFS |
| overall survival (OS) | Up to 10 years | Furthermore, we provided Kaplan-Meier plots for OS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of the SYSUCC-RMS regimen for pediatric RMS patients. | Up to 10 years | Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0. |
Countries
China
Contacts
Primary ContactSuying Lu
Outcome results
None listed