Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
26/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.siopel.org/

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 measures

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

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

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom

Sponsor type

Government

Website

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes