PHITT
Research type
Research Study
Full title
Paediatric Hepatic International Tumour Trial
IRAS ID
212527
Contact name
Madhumita Dandapani
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2016-002828-85
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 8 months, 31 days
Research summary
PHITT is an international, phase III, open-label trial with 4 randomised comparisons for paediatric, adolescent and adult patients with newly diagnosed hepatoblastoma (HB) and hepatocellular carcinoma (HCC), which are types of liver cancer.
The 5 year overall survival (OS) for children with HB ranges from 53-100% depending on the extent of the disease and risk factors. Among those ‘cured’, current treatment regimens have significant side effects including cisplatin induced hearing loss and kidney problems, doxorubicin induced heart problems and secondary cancers.
This study aims to reduce treatment for the very low and low risk group patients, while maintaining the excellent event-free survival (EFS) in these groups to reduce side effects of treatment. Intensification of therapy in the high risk group aims to improve the surgery options available and the EFS, while testing the use of new drugs in a clinical trial setting. The study also seeks to compare different regimens to improve surgical options in intermediate risk HB. Evaluation of the biology and genetics of HB and HCC as part of this study will identify prognostic and toxicity biomarkers.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0110
Date of REC Opinion
10 Apr 2017
REC opinion
Further Information Favourable Opinion