Stratified treatment for pediatric rhabdomyosarcoma based on risk factors
A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.
This study is testing a new treatment plan for children with rhabdomyosarcoma to see if combining chemotherapy and radiotherapy helps improve survival based on their risk levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06836492 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of the SYSUCC-RMS treatment regimen for children diagnosed with rhabdomyosarcoma (RMS). It will assess the impact of combining chemotherapy and radiotherapy on survival rates across different risk categories: low, medium, high, and extremely high risk. The study will include pediatric patients aged 0 to 18 years who are receiving treatment for the first time and will monitor their outcomes based on their specific risk factors.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who have been newly diagnosed with rhabdomyosarcoma.
Not a fit: Patients with immunodeficiency diseases or those who have a second tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for children with rhabdomyosarcoma, improving survival rates.
How similar studies have performed: Other studies have shown promise in stratified treatment approaches for pediatric cancers, suggesting potential success for this methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Suying Lu — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Suying Lu
- Email: lusy@sysucc.org.cn
- Phone: +020-87342460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.