This study investigates the event-free survival of patients with intermediate-risk rhabdomyosarcoma (IR RMS), a type of cancer that forms in soft tissue, treated with different combinations of surgery, radiotherapy, and chemotherapy. The study compares two treatment arms: one involving surgery, radiotherapy, and a chemotherapy regimen called VAC/VI, and the other involving the same treatment with the addition of an investigational medication.

Participants in this study will undergo standard cancer treatments such as surgery and radiotherapy. Additionally, they will receive chemotherapy, which involves the use of drugs to kill cancer cells. The study will compare the outcomes of those receiving the investigational medication along with the standard treatment to those receiving only the standard treatment.

• Who can participate: Patients with newly diagnosed rhabdomyosarcoma (RMS), excluding adult-type pleomorphic, can participate. They must have adequate bone marrow, renal, and liver function, and provide sufficient tissue for study. Those who have received certain treatments or have specific health conditions are excluded.
• Study details: Participants will undergo surgery, radiotherapy, and chemotherapy. Some will also receive an investigational medication. A placebo is not used in this study.