SIOPEL-3 Liver Tumour Studies: hepatoblastoma and hepatocellular carcinoma
| ISRCTN | ISRCTN87675276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87675276 |
| Secondary identifying numbers | LT1998/01 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cisplatin, doxorubicin |
| Primary outcome measure | Complete resection |
| Secondary outcome measures | Toxicity measures, survival and event-free survival |
| Overall study start date | 01/06/1998 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JN
United Kingdom
WC1N 3JN
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom
"ROR" |
https://ror.org/02fha3693 |
|---|
Funders
Funder type
Research organisation
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/06/2017: No publications found in PubMed, verifying study status with principal investigator.
