Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma

Inclusion Criteria: * written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available * pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review * Rhabdomyosarcoma of the "High Risk" Group, i.e.: * RME, N0, M0, IRS II\&III, \>5 cm or \>10 years in EXT, HN-PM, OTH, UG-BP * RME, N1, M0, any IRS-group, any size or age * RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or * Rhabdomyosarcoma of the "Very High Risk" Group, i.e.: * RMA, N1, MO, IRS II\&III, any size or age or * localised high-risk RMS-like Soft Tissue Sarcoma, i.e.: * EES, pPNET, UDS: any N, M0, any IRS-group, any size or age * SySa, any N, M0, any size or age (exception: SySa IRSI\&II, not T2b, N0, M0 are not eligible) * no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity) * no previous malignant tumours * available for long term follow up through the treating centre * in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance Exclusion Criteria: * pregnant or lactating women * other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.) * for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)