History

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SIOPEL 1 – 1990/1994

This trial collected 194 evaluable patients (154 with HB and 40 with HCC) and investigated the role of the cisplatin/doxorubicin combination chemotherapy. The trial also served to test a new staging approach termed PRETEXT (Pre-Treatment Tumor Extension).

SIOPEL 2 – 1994/1998

This trial collected 155 evaluable patients (135 with HB and 20 with HCC) and introduced a treatment stratification for hepatoblastoma according to previous SIOPEL 1 prognostic findings with 2 risk categories: standard risk and high risk. Standard risk patients were treated with cisplatin alone in order to avoid the potential cardiotoxicity associated with doxorubicin, whereas high risk patients were treated with the combination of cisplatin/doxorubin/carboplatin.

SIOPEL 3 – 1998/2004-2005

This trial collected 471 evaluable patients (406 with HB and 65 with HCC) and was a prospective randomised clinical trial on standard risk   hepatoblastoma (SIOPEL3 SR-HB – 1998-2005) and a prospective single arm trial on high risk hepatoblastoma (SIOPEL 3 HR-HB – 1998-2004). The trial consisted of a phase II trial for high risk HB, a phase II for all HCC, a phase II on high-dose cyclophosphamide for relapsed patients and a randomized phase III non-inferiority trial for standard risk HB. The latter tested the hypothesis that it is safe to omit doxorubicin for such patients and to treat them with cisplatin alone.

SIOPEL 4 – 2005/2009

This was the study on high risk hepatoblastoma which collected 61 evaluable HB patients. This trial introduced a treatment of HR-HB with dose intensive Cisplatin-based chemotherapy.

SIOPEL 5 – 06/2005-2009 – closed due to insufficient recruitment

This was the first prospective single arm trial devoted exclusively to the hepatocellular carcinoma family of tumors.

Phase II study on High dose Cyclophosphamide – 1996/2001  A

 

Phase II study on Irinotecan (it collected 24 evaluable HB patients) – 2003/2008

 

Currently the group is running following projects:

  • An International Tissue Bank for Childhood Liver Tumours – M. Grotzer (SUI)
  • A new single arm trial for standard risk hepatoblastoma; SIOPEL 6 – opened in – Trial main coordinators: Penelope Brock (UK), Gustav Osterlundh (Sweden), Mike Sullivan (NZ)
  • A prospective single arm trial in cooperation with the Indian Paediatric Oncology Society – SIOPEL RCN – M.Ronghe (UK) and Dr.Sandeep Agarwala, AIIMS, Delhi, (India).
  • Global cooperation in the field of creating common retrospective patients’ database in liver tumors – CHIC project (together with USA – COG, Germany – GPOH and Japan – JPLT) – Project leaders: Rebecka Meyers (USA), Mark Krailo (USA), Rudolf Maibach (SUI), Piotr Czauderna (PL), Dietrich v. Schweinitz (D), Eiso Hiyama (JPN).
  • The Pathogenesis and Prognostic Stratification of Hepatoblastoma and Hepatocilliar Carcinoma by micro array gene expression analysis: A collaborative study with the SIOPEL Group – Mike Sullivan (NZ)
  • Investigation into possible molecular mechanism leading to the development of non-cirrhotic liver cancer in adolescents and young adults: the role of the Serpin SCCA - Patrizia Pontisso (Italy)
  • Prognostic factors in Hepatoblastoma: Protein expression analysis of the 16-gene signature – Carolina Armengol, (Spain)