RhabdomyosarcomaPhase 3NCT06836492
A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors.
A Phase 3 study testing VAC，VAC/VII，CAV/IE in people with Rhabdomyosarcoma and Pediatric Cancer, run by Yizhuo Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Rhabdomyosarcoma, Pediatric Cancer
- What is being tested?
- VAC，VAC/VII，CAV/IE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2017to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 0 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.
Who cannot join
- Combined with immunodeficiency disease
- Second tumor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suying Lu
Guangzhou, Guangdong, 510060
Suying Lu, +020-87342460, lusy@sysucc.org.cn
About this study
Official title: A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.
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.
- Conditions
- Rhabdomyosarcoma, Pediatric Cancer
- Being tested
- VAC，VAC/VII，CAV/IE
- Medical subject headings
- Rhabdomyosarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC，VAC/VII，CAV/IECombination product
Low risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP
| Study group | Role | What they receive |
|---|---|---|
| Low risk | Other | Not described Receives: Combination Product: VAC，VAC/VII，CAV/IE |
| Moderate risk | Other | Not described Receives: Combination Product: VAC，VAC/VII，CAV/IE |
| High risk | Other | Not described Receives: Combination Product: VAC，VAC/VII，CAV/IE |
| Very high risk | Other | Not described Receives: Combination Product: VAC，VAC/VII，CAV/IE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR)
The ORR was calculated based on the best overall response.
Measured: Up to 1 year
disease control rate (DCR)
Measured: Up to 1 year
progression-free survival (PFS)
Furthermore, we provided Kaplan-Meier plots for PFS
Measured: Up to 10 years
overall survival (OS)
Furthermore, we provided Kaplan-Meier plots for OS.
Measured: Up to 10 years
Secondary outcomes (1)
The safety of the SYSUCC-RMS regimen for pediatric RMS patients.
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start30 Jan 2017
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yizhuo Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836492
- Sponsor's protocol ID
- SYSUCC-RMS
- Status last verified
- Jan 2025
- First submitted
- 8 Aug 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.
- ClinicalTrials.gov ID
- NCT06836492
- Acronym / sponsor ID
- SYSUCC-RMS
- Conditions
- Rhabdomyosarcoma, Pediatric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yizhuo ZhangUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 0 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;
Key exclusion criteria (2 listed)
- Combined with immunodeficiency disease
- Second tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAC，VAC/VII，CAV/IELow risk: VAC Intermediate risk: VAC/VII High risk: CAV/IE Very high risk: CAV/VIP | Combination product | High risk, Low risk, Moderate risk, Very high risk |
Primary outcome
The objective response rate (ORR)
Time frame: Up to 1 year
The ORR was calculated based on the best overall response.
disease control rate (DCR)
Time frame: Up to 1 year
progression-free survival (PFS)
Time frame: Up to 10 years
Furthermore, we provided Kaplan-Meier plots for PFS
overall survival (OS)
Time frame: Up to 10 years
Furthermore, we provided Kaplan-Meier plots for OS.
1 secondary outcome
The safety of the SYSUCC-RMS regimen for pediatric RMS patients.
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Rhabdomyosarcoma
Active, not recruitingPhase 1/2
VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
Solid Tumor, Rhabdomyosarcoma
Not yet recruiting
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Sarcoma, Osteosarcoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VAC，VAC/VII，CAV/IE in people with Rhabdomyosarcoma and Pediatric Cancer, run by Yizhuo Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suying Lu (+020-87342460, lusy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective response rate (ORR) (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.