Trial | NCT00876031  Report issue

Title

Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
A Randomised Phase-III Trial of the Cooperative Weichteilsarkom Study Group (CWS) for Localised High-risk Rhabdomyosarcoma and Localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in Children, Adolescents, and Young Adults

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    195
The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma.
Study Started
Jul 01
2009
Primary Completion
Jun 30
2022
Study Completion
Jun 30
2022
Last Update
Nov 08
2022

Drug trofosfamide, idarubicin, etoposide

oral maintenance therapy for 6 months

O-TIE Experimental

oral maintenance therapy with trofosfamide, idarubicin, and etoposide

control No Intervention

Criteria 

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)
No Results Posted