A Protocol for Non Metastatic Rhabdomyosarcoma

1. PROTOCOL SPONSOR

It is responsibility of each participating national Group or Institution to arrange sponsorship in line with the requirements of the European Union directive on Good Clinical Practice in Clinical Trials.

2. Protocol Co-ordination

This protocol is co-ordinated by the European paediatric Soft tissue sarcoma Study Group (in its abbreviated form EpSSG). This new collaborative structure has been founded by

The Co-operative Weichteilsarkom Studie (CWS)
The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)
(former ICG: Italian Cooperative Group for paediatric soft tissue sarcoma)
The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)

These Groups decided to join forces to design and implement a portfolio of pan-European studies addressed at children and adolescents affected by soft tissue sarcoma.

This study will not introduce or try to license chemotherapeutic agents for treatment of paediatric sarcoma. Treatment will rely on already licensed and introduced chemotherapeutic drugs. Therefore, chemotherapeutic agents and other therapeutic substances needed for treatment in EpSSG RMS 2005 will not be paid for by the study nor will these substances be provided by pharmaceutical companies.

6. Summary

Three Cooperative Groups have been working in Europe on paediatric soft tissue sarcoma for the last twenty years: the SIOP MMT Committee, the CWS and the AIEOP STSC (former ICG). Cooperation has intensified over the last few years and has led to the foundation of the European paediatric Soft tissue sarcoma Study Group (EpSSG). This is the first EpSSG protocol and it addresses the treatment of children and young people presenting with non-metastatic rhabdomyosarcoma.

PATIENTS ELIGIBILITY

A) To the observational study

Patients with pathologically confirmed rhabdomyosarcoma
No evidence of metastatic disease
Age 0 - < 21 years