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Study identifier: NCT04994132 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

Condition: Alveolar Rhabdomyosarcoma · Botryoid-Type Embryonal Rhabdomyosarcoma · Embryonal Rhabdomyosarcoma  ·  Sponsor: Children's Oncology Group

PhasePhase 3
Planned participants113
Who can joinAll sexes, N/A to 50 Years
Healthy volunteersNo

About this study

This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (250)

Children's Hospital of AlabamaBirmingham, Alabama, United States
USA Health Strada Patient Care CenterMobile, Alabama, United States
Providence Alaska Medical CenterAnchorage, Alaska, United States
Kingman Regional Medical CenterKingman, Arizona, United States
Banner Children's at DesertMesa, Arizona, United States
Phoenix Childrens HospitalPhoenix, Arizona, United States
Banner University Medical Center - TucsonTucson, Arizona, United States
Arkansas Children's HospitalLittle Rock, Arkansas, United States
Kaiser Permanente-AnaheimAnaheim, California, United States
PCR OncologyArroyo Grande, California, United States
Kaiser Permanente-BellflowerBellflower, California, United States
Kaiser Permanente Downey Medical CenterDowney, California, United States

+ 238 more locations — full list on the registry record.

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