Skip to main content
← All trials
Embryonal RhabdomyosarcomaGeneticsChildren's healthProcedureDrugBiologicalRadiationPhase 3

What this study is

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.

What's being tested

  • Biopsy Procedure

    Intervention · PROCEDURE

    Undergo tumor biopsy

  • Bone Scan

    Intervention · PROCEDURE

    Undergo bone scan

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT scan

  • Cyclophosphamide

    Intervention · DRUG

  • Dactinomycin

    Intervention · BIOLOGICAL

  • Magnetic Resonance Elastography

    Intervention · PROCEDURE

    Undergo MRI

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET scan

  • Radiation Therapy

    Intervention · RADIATION

    Undergo radiation

  • Vincristine

    Intervention · DRUG

All of Cyclophosphamide, Dactinomycin, Vincristine

Given IV

Study details

Official title
A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma
Sponsor
Children's Oncology Group
Conditions
Embryonal Rhabdomyosarcoma · Fusion-Negative Alveolar Rhabdomyosarcoma · Spindle Cell/Sclerosing Rhabdomyosarcoma
Enrolling
205 people
Starts
2022-08-04
Est. completion
2030-06-30
Design
Open-label, non-randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗