SIOPEL-3 Liver Tumour Studies: hepatoblastoma and hepatocellular carcinoma
| ISRCTN | ISRCTN87675276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87675276 |
| Protocol serial number | LT1998/01 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 09/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Penelope Brock
Scientific
Scientific
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JN
United Kingdom
| Phone | +44 (0)20 7405 9200 |
|---|---|
| brockp@gosh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | SIOPEL-3 Liver Tumour Studies: hepatoblastoma and hepatocellular carcinoma |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hepatoblastoma and hepatocellular carcinoma |
| Intervention | 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). |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cisplatin, doxorubicin |
| Primary outcome measure(s) |
Complete resection |
| Key secondary outcome measure(s) |
Toxicity measures, survival and event-free survival |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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) |
| Key exclusion criteria | Pretext 4, extra hepatic disease, lung metastases, tumour rupture. |
| Date of first enrolment | 01/06/1998 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JN
United Kingdom
WC1N 3JN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/06/2017: No publications found in PubMed, verifying study status with principal investigator.
