Siopel-5 (HCC-1) trial on the hepatocellular carcinoma family of tumours in children/adolescents and young adults
| DEC-NET Serial number GB439 | |
| Published online | 04/07/2005 12.24.00 |
| Last updated | 09/08/2005 11.36.03 |
| This trial has been approved by an ethics committee | |
| Current trial status | Planned (i.e. not yet recruiting participants) |
| Major Disease (ICD9 class) | CARCINOMA IN SITU OF LIVER AND BILIARY SYSTEM |
| Experimental drug | |
| Cisplatin | |
| CYCLOPHOSPHAMIDE | |
| Thalidomide | |
| Doxorubicin | |
| Gender | Both |
| Age (range) | 0 - 29 years |
Eligibility criteria | |
| Inclusion criteria | |
| No prior treatment for Hepatocellular carcinoma, non-cirrhotic hepatocellular carcinoma, negative pregnancy test, biopsy proven hepatocellular carcinoma. | |
| Exclusion criteria | |
| Life expectancy< 3 months, inability to follow the protocol, abnormal renal or cardiac function. | |
Trial design/methodology | |
| Phase | 2 |
| Kind of study | Efficacy Safety |
| Design | Single arm |
| Purpose of study | |
| Improved Survival | |
| Primary outcomes | |
| Survival | |
| Secondary outcomes | |
| Response to chemotherapy, toxicity | |
| Summary of study design, objectives, and ongoing research findings | |
| A phase II multicentred, multinational trial to improve event-free and overall survival of patients with non-cirrhotic hepatocellular carcinoma (HCC). | |
| Principal investigator | |
| Name | Dr Bruce Morland |
| Institution | Birmingham Children's Hospital |
| Postal address | Bimingham Children's Hospital, Steelhouse Lane, |
| City | Birmingham |
| Country | UNITED KINGDOM |
| Phone | 0121 333 8233 |
| Fax | 0121 333 8241 |
| bruce.morland@bch.nhs.uk | |
| International lead principal investigator (for international trials) | |
| Name | Dr P. Czauderna |
| Institution | Medical University of Gdansk |
| Postal address | Department Of Pediatric Surgery, U1. Nowe Ogrody 1-6 Gdansk 80-803 |
| City | Gdansk |
| Country | Poland |
| Phone | |
| Fax | |
| pczaud@amedec.amg.gda.pl | |
| Sponsor name |
| University Hospital Leicester NHS Trust (University) |
| Participating countries |
| UNITED KINGDOM |
| Participating centres |
| Addenbrookes Hospital (Addenbrookes) |
| Great Ormand Street Hospital for Children (London) |
| The Middlesex Hospital (London) |
| Children's Hospital for Wales (Cardiff) |
| Sheffield Children's Hospital (Sheffield) |
| Birmingham Children's Hospital (Birmingham) |
| Leicester Royal Infirmary (Leicester) |
| Southhampton General Hospital (Southampton) |
| Our Lady's Hospital for Sick Children (Dublin) |
| Royal Victoria Hospital (Newcastle-Upon-Tyne) |
| Royal Aberdeen Children's Hospital (Aberdeen) |
| Royal Hospital for Sick Children (Glasgow) |
| Queen's Medical Centre (Nottingham) |
| Royal Hospital For Sick Children (Bristol) |
| Alder Hey Children's Hospital (Liverpool) |
| John Radcliffe Hospital (Oxford) |
| Royal Hospital for Sick Children (Edingburgh) |
| Royal Manchester Children's Hospital (Manchester) |
| Royal Hospital for Sick Children (Belfast) |
| St. James University Hospital (Leeds) |
| Royal Marsden Hospital (Sutton) |
| ISRCTN | EudraCT 2005-000427-42 |
