| Source of record | UK Trials |
| ISRCTN | ISRCTN87675276 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LT1998/01 |
| Public title | SIOPEL-3 Liver Tumour Studies: Hepatoblastoma and hepatocellular carcinoma |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Liver |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Diagnosis is hepatoblastoma
2. Pretext is I, II or III
3. No extrahepatic Involvement
4. Age <16 at diagnosis
5. No prior treatment
6. No primary surgery required
7. Lung CT scan performed
8. Initial serum alpha-feta protein value obtained (greater than or 100 ng/ml) |
| Participants - exclusion criteria | Pretext 4, extra hepatic disease, lung metastases, tumour rupture. |
| Patient information material |
|
| Anticipated start date | 01/06/1998 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Target number of participants | 500+ |
| Interventions | Standard risk hepatoblastoma
Arm 1:
Initial Treatment - 1 course cisplatin. Continuation treatment - 5 courses cisplatin/doxorubicin.
Surgery after course 3 (if feasible).
Arm 2:
Initial treatment - 1 course cisplatin. Continuation treatment - 5 courses cisplatin.
Surgery after course 3 (if feasible). |
| Primary outcome measure(s) | Complete resection |
| Secondary outcome measure(s) | Toxicity measures, survival and event free survival |
| Trial website | http://www.siopel.org/ |
| Sources of funding | Cancer Research UK |
| Sponsor name | University Hospitals of Leicester NHS Trust (UK) |
| Sponsor details | Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
United Kingdom
LE5 4QF |
| Contact name | Dr Penelope Brock |
| Contact details | Great Ormond Street Hospital
Great Ormond Street
London
United Kingdom
WC1N 3JN |
| Contact telephone | +44 (0) 20 7405 9200 |
| Contact fax | +44 (0) 20 7813 8588 |
| Contact email | brockp@gosh.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN87675276 |
| Date last extracted from ISRCTN register | 17/04/2008 |
