Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma (CWS-2007-HR)

University Hospital Tuebingen

Status and phase

Completed

Phase 3

Conditions

Soft Tissue Sarcoma

Treatments

Drug: trofosfamide, idarubicin, etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT00876031

A2007/14 (Kinderkrebsstiftung) (Other Identifier)

2007-001478-10 (EudraCT Number)

498 (Krebsstudienregister) (Registry Identifier)

CWS-2007-HR

293/2007AMG1 (Ethikkommission) (Other Identifier)

4033024 (BfArM) (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

195 patients

Sex

All

Ages

6 months to 21 years old

Volunteers

No 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)