Health conditions
(Datenquelle: WHO)
Hepatoblastoma;Carcinoma, Hepatocellular
Interventions (Datenquelle: WHO)
Drug: Cisplatin;Drug: Doxorubicin;Drug: Carboplatin;Drug: 5Fluorouracil;Drug: Vincristine;Drug: Etoposide;Drug: Irinotecan;Drug: Gemcitabine;Drug: Oxaliplatin;Drug: Sorafenib
Inclusion/Exclusion Criteria
(Datenquelle: 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
-
Weitere Informationen zur Studie
Datum der Studienregistrierung
14.12.2016
Einschluss der ersten teilnehmenden Person
24.08.2017
Rekrutierungsstatus
Recruiting
Wissenschaftlicher Titel
(Datenquelle: WHO)
Paediatric Hepatic International Tumour Trial
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Datenquelle: WHO)
Phase 3
Primäre Endpunkte
(Datenquelle: WHO)
Event-free survival (EFS);Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria
Sekundäre Endpunkte
(Datenquelle: 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
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: WHO)
Austria, Belgium, Czechia, France, Germany, Ireland, Israel, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom
Weitere Studienidentifikationsnummern
Secondary ID (Datenquelle: WHO)
RG_15-114
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