A Phase III Study to Compare Early Use of Vinorelbine and Maintenance Therapy for People with High-Risk Rhabdomyosarcoma


Full Title

A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS) (ARST2031) (CIRB)


The purpose of this study is to compare the safety and effectiveness of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) therapy to treat children, teens, and young adults with high-risk rhabdomyosarcoma. High-risk cancers are likely to come back after treatment or spread to other parts of the body. Researchers will determine if using vinorelbine with VAC therapy and during maintenance therapy will help eliminate the cancer and/or lower the risk of recurrence.

Vinorelbine, vincristine, dactinomycin, and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. Participants in this study will be randomly assigned to receive VAC alone or with vinorelbine. Both groups will then receive maintenance therapy with vinorelbine and cyclophosphamide.

Who Can Join

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

  • Participants must have newly diagnosed high-risk rhabdomyosarcoma that has not yet been treated with chemotherapy.
  • This study is for people age 50 and younger.


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




Phase III (phase 3)

Disease Status

Newly Diagnosed



ClinicalTrials.gov ID