A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in children and adolescents, with approximately 350 children diagnosed annually in the United States. Patients are divided into low, intermediate, and high-risk groups based on the characteristics of their disease. The overall goals of this study are: 1. To compare the effects, good and/or bad, of giving less chemotherapy drugs to people with VLR-RMS to find out which is better. This is Arm VLR-RMS of the study. 2. To find out how well people with LR-RMS as a group respond to standard chemotherapy when risk groups are refined so that people with VLR-RMS and people who have RMS with DNA mutations are removed from the LR group and get separate treatment. This is Arm LR-RMS of the study. 3. To describe the effects, good and/or bad, of giving chemotherapy drugs for longer amount of time to people who have RMS cancer with DNA mutations to see if they benefit from longer therapy than if they continued on VLR or LR therapy. This is Arm M of the study

Are you Eligible? (Inclusion Criteria)

• Patients must be less than or equal to 21 years at the time of enrollment -Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). -Patients must also meet all eligibility criteria as outlined in the study protocol