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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876031

Acronym

CWS-2007-HR

Enrollment

195

Registered

2009-04-06

Start date

2009-07-01

Completion date

2022-06-30

Last updated

2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Sarcoma

Keywords

pediatric soft tissue sarcoma, rhabdomyosarcoma, extraosseous Ewing family tumours, synovial sarcoma, undifferentiated sarcoma

Brief summary

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.

Interventions

DRUGtrofosfamide, idarubicin, etoposide

oral maintenance therapy for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 21 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
event free survival (EFS)	3 years

Secondary

Measure	Time frame
Overall survival	5 years

Countries

Austria, Germany, Poland, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026