localized High Risk Soft Tissue Sarcoma in patients younger than 21 years MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Idarubicin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: IDARUBICIN
CAS Number: 58957929
Product Name: Trofosfamide
Pharmaceutical Form: Tablet
INN or Proposed INN: TROFOSFAMI
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Inclusion 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 • age > 6 months and 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 • no previous malignant tumours • available for long term follow up through the treating centre • in remission (according to the CWS-2007-HR definition (see 7.1.8)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance for 25 weeks Are the trial subjects under 18? yes Number of subjects for this age range: 275 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • pregnant or lactating women • other medical condition precluding treatment with protocol (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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 RMSlike Soft Tissue Sarcoma;Secondary Objective: 1. To investigate, whether the additon of oral maintenance therapy (O-TIE) for 6 months after multimodal standard therapy has impact on following outcomes: overall survival (OS), short-term toxicity and late effects in patients with localised high-risk RMS and RMS-like STS 2. To reassess the European consensus on risk-stratification for RMS within the network of the European paediatric Soft Tissue Sarcoma Study Group (EpSSG) 3. To collect tumour and associated bone marrow/blood specimens (as part of the Tumorbank of the GPOH Kompetenznetz) to enable further analysis of molecular characteristics of STS which will provide a more objective base for a new, improved classification and therapeutic decisions. 4. To compare the results of CWS-2007-HR with respect to EFS, OS, shortand long-term toxicities and quality of life (in a cooperation with the Late Effects Board of the GPOH) with the results of previous CWS and other trials within the European EpSSG-network. ;Primary end point(s): • 3-year Event Free Survival ;Timepoint(s) of evaluation of this end point: After 3 years of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 5-year Overall Survival;Timepoint(s) of evaluation of this end point: Afer 5 years of follow-up | — |
Countries
Austria, Germany, Poland, Sweden, Switzerland
Contacts
Public ContactCWS study group centre
CWS study group
Outcome results
None listed