A Phase III Study of Different Treatments for People Newly Diagnosed with Very Low-Risk and Low-Risk Rhabdomyosarcoma

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Full Title

A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma (ARST2032) (CIRB)

Purpose

Rhabdomyosarcoma (RMS) is a type of cancer that occurs in the soft tissues in the body. Researchers in this study are comparing different chemotherapy-based treatments for children and young adults with very low-risk RMS, low-risk RMS, and RMS with DNA mutations, with treatment tailored to the predicted aggressiveness of each patient’s cancer. The standard chemotherapy drugs participants will receive include vincristine, dactinomycin, and cyclophosphamide.

There are three groups in this study:

  • People with very low-risk RMS will receive less intensive chemotherapy.
  • Patients with low-risk RMS will receive standard chemotherapy.
  • Participants with RMS who have DNA mutations will receive longer therapy than the other two groups. In addition to chemotherapy, they may also receive radiation therapy.

The goal of this approach is to tailor chemotherapy to each patient according to the risk status of their cancer to maximize treatment effectiveness while minimizing side effects. The chemotherapy drugs used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must be newly diagnosed with RMS that has not yet been treated.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 21 and younger.

Contact

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

22-299

Phase

III

Investigator

Co-Investigators

Diseases