Eligibility
< 65
All Sexes
What conditions do you have?
Select
Study Summary
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Eligible Conditions
- Rhabdomyosarcoma, Embryonal
- Spindle Cell/Sclerosing Rhabdomyosarcoma
- Fusion-Negative Alveolar Rhabdomyosarcoma
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Up to 5 years
Year 3
Failure free survival (FFS) for low risk patients
Failure free survival (FFS) for very low risk patients
Year 5
Failure free survival (FFS)
Year 5
Overall survival (OS)
Overall survival (OS) for low risk patients
Overall survival (OS) for very low risk patients
Up to 24 weeks
Feasibility of central molecular risk stratification of patients assessed by the percentage of patients who have molecular testing results returned by 6 weeks
Up to 5 years
Methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
4 Treatment Groups
Regmine VA (VLR RMS)
1 of 4
Regimen M (positive mutation)
1 of 4
Regimen VA (VLR RMS)
1 of 4
Regimen VAC/VA (VL RMS)
1 of 4
Experimental Treatment
205 Total Participants · 4 Treatment Groups
Primary Treatment: Radiation Therapy · No Placebo Group · Phase 3
Regmine VA (VLR RMS)Experimental Group · 2 Interventions: Vincristine, Dactinomycin · Intervention Types: Drug, Biological
Regimen M (positive mutation)Experimental Group · 4 Interventions: Vincristine, Dactinomycin, Radiation Therapy, Cyclophosphamide · Intervention Types: Drug, Biological, Radiation, Drug
Regimen VA (VLR RMS)Experimental Group · 2 Interventions: Vincristine, Dactinomycin · Intervention Types: Drug, Biological
Regimen VAC/VA (VL RMS)Experimental Group · 3 Interventions: Vincristine, Dactinomycin, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
2003
Completed Phase 4
~2820
Dactinomycin
2010
Completed Phase 3
~790
Radiation Therapy
2005
Completed Phase 3
~7080
Cyclophosphamide
1995
Completed Phase 3
~4020
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Washington University School of Medicine · Saint Louis, MO
2004First Recorded Clinical Trial
13 TrialsResearching Rhabdomyosarcoma, Embryonal
1474 CompletedClinical Trials
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
444 Previous Clinical Trials
233,296 Total Patients Enrolled
16 Trials studying Rhabdomyosarcoma, Embryonal
3,451 Patients Enrolled for Rhabdomyosarcoma, Embryonal
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,255 Total Patients Enrolled
31 Trials studying Rhabdomyosarcoma, Embryonal
5,122 Patients Enrolled for Rhabdomyosarcoma, Embryonal
Josephine H HaduongPrincipal InvestigatorChildren's Oncology Group
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are between the ages of 18 and 21.
Patients with paratesticular tumors who are 10 years of age or older and who do not have gross nodal involvement on imaging should undergo SIRLNS.
Patients with extremity tumors must have regional lymph node sampling.
Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
Patients must be able to walk, or have a performance score of 50 or higher.
Patients must have embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing rhabdomyosarcoma (SC/SRS), or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Top Oncology Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments