Paediatric Hepatic International Tumour Trial

Summary

The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment of children diagnosed with HB.

Children with HCC will be included as a separate cohort.

Conditions

• Hepatoblastoma
• Carcinoma, Hepatocellular

Interventions

DRUG

Cisplatin

Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination

DRUG

Doxorubicin

Arms C, D and E used in combination

DRUG

Carboplatin

Arms C and D used in combination

DRUG

5Fluorouracil

Arm C used alone

DRUG

Vincristine

Arms C and D used in combination

DRUG

Etoposide

Arm D used in combination

DRUG

Irinotecan

Arm D used in combination

DRUG

Gemcitabine

Arm F used in combination

DRUG

Oxaliplatin

Arm F used in combination

DRUG

Sorafenib

Arm used in combination

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol

  collaborator OTHER

• University Hospital Munich

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• University of Kiel

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Motol University Hospital

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• Children's University Hospital, Ireland

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Princess Maxima Center for Pediatric Oncology

  collaborator OTHER

• Andaluz Health Service

  collaborator OTHER_GOV

• Swiss Pediatric Oncology Group

  collaborator OTHER

• Gothia Forum - Center for Clinical Trial

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Bambino Gesù Hospital and Research Institute

  collaborator OTHER

• Newcastle University

  collaborator OTHER

• Experimental Cancer Medicine Centres

  collaborator OTHER

• XenTech, Evry

  collaborator UNKNOWN

• University of Birmingham

  lead OTHER

Principal Investigators

• Madhumita Dandapani, MD PhD · University of Nottingham

• Marc Ansari, MD · University of Geneva, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-24

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• Austria
• Belgium
• Czechia
• Finland
• France
• Germany
• Ireland
• Israel
• Netherlands
• Norway
• Poland
• Spain
• Switzerland
• United Kingdom

Study Locations