Contact information
Type
Scientific
Primary contact
Dr Penelope Brock
ORCID ID
Contact details
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JN
United Kingdom
+44 (0)20 7405 9200
brockp@gosh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LT1998/01
Study information
Scientific title
SIOPEL-3 Liver Tumour Studies: hepatoblastoma and hepatocellular carcinoma
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Cisplatin, doxorubicin
Primary outcome measure
Complete resection
Secondary outcome measures
Toxicity measures, survival and event-free survival
Overall trial start date
01/06/1998
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
500+
Participant exclusion criteria
Pretext 4, extra hepatic disease, lung metastases, tumour rupture.
Recruitment start date
01/06/1998
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great Ormond Street Hospital
London
WC1N 3JN
United Kingdom
Funders
Funder type
Research organisation
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list