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.
Additional locations may be listed on ClinicalTrials.gov for NCT03017326.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
The trial will evaluate whether reducing treatment for low risk HB patients maintains
their excellent event free survival (EFS) and decreases acute and long-term toxicity.
Intensification of therapy with the use of novel agents will be evaluated in the high
risk group. The trial will also compare three different regimens in intermediate risk HB.
Patients with HCC will be divided into groups based on whether the tumour is resectable
or unresectable and/or metastatic.
Evaluation of the biology of HB and HCC, using the identification/validation of novel and
already reported prognostic biomarkers as well as toxicity biomarkers is a key strand of
this trial, so patients in all risk groups can be registered. The trial is also designed
to optimise the collection of clinically annotated biologic specimens and establish the
world's largest repository of blood and tissue samples from paediatric patients with HB
and HCC.
The trial includes 4 randomised comparisons addressing therapeutic questions. For low
risk HB patients, outcome with a total of 4 cycles of treatment is not inferior to those
receiving a total of 6 cycles of treatment.
For intermediate risk patients, 3 regimens will be compared for outcome and toxicity.
For high risk patients, 2 post induction regimens will be compared for outcome. For
resected HCC patients, the addition of GEMOX to PLADO regimen will be compared.
In addition the following will be assessed:
- To validate a new global risk stratification, defined by Children's Hepatic Tumours
International Collaboration (CHIC)
- To evaluate clinically relevant factors, including the following:
- Provide a comprehensive and highly-validated panel of diagnostic and prognostic
biomarkers
- Determine if paediatric HCC is a biologically different entity to adult HCC
- Develop genomic and/or biomarker analysis to predict children who may have an
increased risk of developing toxicity with chemotherapy.
- To establish a collection of clinically and pathologically-annotated biological
samples.
- Evaluate a surgical planning tool for an impact on decision making processes in
POST-TEXT III and IV HB
Lead OrganizationUniversity of Birmingham
