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- 2018-000515-24, ISRCTN45535982
An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma
Other Non-Commercial Sponsor
University of Birmingham & Cancer Research UK
The first part of this study will be a phase Ib dose-finding trial, open to newly diagnosed patients. This study will investigate the addition of irinotecan to IVA (ifosfamide, vincristine and actinomycin D) chemotherapy (IrIVA) and support the identification of a recommended phase II dose. Once the recommended phase II dose has been determined, patients will be randomised, according to whether they are newly diagnosed or high risk, into the next part of the study. In this part of the study, newly diagnosed patients will be randomised to receive either IVADo (Ifosfamide, Vincristine, Actinomycin D, Doxorubicin) or IrIVA; and high risk patients will be randomised to IVA or IrIVA. Cycles of chemotherapy will be given at 21-day intervals. The next part of the study will contain several radiotherapy randomisations for patients with newly diagnosed and high risk rhabdomyosarcoma, followed by maintenance chemotherapy. Following the completion of treatment, the frequency of follow-up assessments will be guided by local practice. However, every 3 months for the first 3 years and every 6 months thereafter is suggested. Patients will be followed-up for a minimum of 3 years, until the last patient has been followed-up for 3 years.