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NCT03017326

Paediatric Hepatic International Tumour Trial

Datenbasis: WHO (Import vom 18.04.2024)
Geändert: 02.10.2022, 22:29
Krankheitskategorie:

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 Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03017326

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03017326
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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