Median follow-up was 63♹ months (IQR 44♶–78♹). This trial is registered with EudraCT, number 2005-000217-35,īetween Oct 1, 2005, and Dec 16, 2013, 484 patients were randomly assigned to receiveĮach chemotherapy regimen (242 in the IVA group and 242 in the IVA plus doxorubicin In agreement with the independentĭata monitoring committee, the study was closed to patient entry on Dec 16, 2013,Īfter futility analysis. Treatment were considered in the safety analysis. Patients who received at least one dose of study The primaryĮndpoint was 3-year event-free survival assessed by the investigator at each centre
Neither investigators nor patients were masked to treatment allocation. System and was stratified (block sizes of four) by enrolling country and risk subgroup. Intravenous injection], and dactinomycin 1♵ mg/m 2 on day 1 given as a single intravenous injection) or four cycles of IVA with doxorubicinģ0 mg/m 2 given as a 4-h intravenous infusion on days 1 and 2 followed by five cycles of IVA. Were randomly assigned (1:1) to receive either nine cycles of IVA (ifosfamide 3 g/m 2 given as a 3-h intravenous infusion on days 1 and 2, vincristine 1♵ mg/m 2 weekly during the first 7 weeks then only on day 1 of each cycle [given as a single Nodal involvement were considered at high risk of relapse.
Sites with or without nodal involvement, or those with alveolar rhabdomyosarcoma without Those with embryonal rhabdomyosarcoma incompletely resected and localised at unfavourable We assignedĮach patient to a specific subgroup according to the EpSSG stratification system. Than 21 years with a pathologically proven diagnosis of rhabdomyosarcoma. We included patients older than 6 months but younger We did a multicentre, open-label, randomised controlled, phase 3 trial involving 108
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