Health conditions
(Data source: WHO)
Hepatoblastoma;Carcinoma, Hepatocellular
Interventions (Data source: WHO)
Drug: Cisplatin;Drug: Doxorubicin;Drug: Carboplatin;Drug: 5Fluorouracil;Drug: Vincristine;Drug: Etoposide;Drug: Irinotecan;Drug: Gemcitabine;Drug: Oxaliplatin;Drug: Sorafenib
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Clinical diagnosis of HB* and histologically defined diagnosis of HB or HCC.
*Histological confirmation of HB is required except in emergency situations where:
- a) the patient meets all other eligibility criteria, but is too ill to undergo a
biopsy safely, the patient may be enrolled without a biopsy.
- b) there is anatomic or mechanical compromise of critical organ function by
tumour (e.g., respiratory distress/failure, abdominal compartment syndrome,
urinary obstruction, etc.)
- c) Uncorrectable coagulopathy
- Age =30 years
- Written informed consent for trial entry
Exclusion Criteria:
- Any previous chemotherapy or currently receiving anti-cancer agents
- Recurrent disease
- Previously received a solid organ transplant; other than orthotopic liver
transplantation (OLT).
- Uncontrolled infection
- Unable to follow or comply with the protocol for any reason
- Second malignancy
- Pregnant or breastfeeding women
-
Further information on trial
Date trial registered
Dec 14, 2016
Incorporation of the first participant
Aug 24, 2017
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Paediatric Hepatic International Tumour Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Event-free survival (EFS);Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria
Secundary end point
(Data source: WHO)
Failure-free survival (FFS);Overall survival (OS);Toxicity categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE);Chemotherapy-related cardiac, nephro- and oto-toxicity using Common Terminology Criteria for Adverse Events (CTCAE);Hearing loss according to the SIOP Boston Scale;Best Response;Surgical resectability defined as complete resection, partial resection or transplant;Adherence to surgical guidelines
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: WHO)
Austria, Belgium, Czechia, France, Germany, Ireland, Israel, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom
Further trial identification numbers
Secondary ID (Data source: WHO)
RG_15-114
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