Last updated on November 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sarcoma
  • Age: Between 1 - 21 Years
  • Gender: Male or Female

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)

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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