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| Diagnosis | Rhabdomyosarcoma | Study Status | Open |
| Phase | III |
| Age | up to 50 Years | Randomisation | YES |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | Chemotherapy medications (Cyclophosphamide, Dactinomycin, Vincristine, Vinorelbine), all given intravenously, except for cyclophosphamide that will be taken by mouth too
Patients will also receive radiation therapy when participating to this study.
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| Last Posted Update | 2023-09-28 |
| ClinicalTrials.gov # | NCT04994132 |
International Sponsor
Children's Oncology GroupPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Paul Nathan
Hamilton Health Sciences Centre - Dr. Uma H. Athale
Children’s Hospital of Eastern Ontario (CHEO) - Dr. Donna L. Johnston
Children's Hospital of Western Ontario – Dr. Shayna Zelcer
Centres
Medical contact
Dr. Carol Portwine
Social worker/patient navigator contact
Jane Cassano
Clinical research contact
Sabrina Millson
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
Social worker/patient navigator contact
Sherley Telisma
Clinical research contact
Carol Duchenne
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
Clinical research contact
Mariam Mikhail
Study Description
This phase III trial compares the effect of two chemotherapy drug pathways (vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide) for the treatment of high risk rhabdomyosarcoma.
Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Giving vinorelbine and VAC may kill more tumor cells and adding maintenance therapy after VAC therapy may help get rid of the cancer and/or lower the chance that the cancer comes back.
Inclusion Criteria
- Patients must be =< 50 years of age
- Study is open to all genders
- Patients with newly diagnosed rhabdomyosarcoma (RMS) of any subtype, meeting "high risk" criteria
- Various bloodwork (bilirubin, creatinine, etc) must be within an acceptable range
- Patients must not be pregnant during the duration of the trial
- Additional inclusion and exclusion criteria may apply and will be reviewed by the study team
