NCT03017326

Paediatric Hepatic International Tumour Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Hepatoblastoma
• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-24
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2017-01-11
• Last updated: 2024-05-13

Locations

32 sites across 14 countries: Austria, Belgium, Czechia, Finland, France, Germany, Ireland, Israel, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom