Paediatric Hepatic International Tumour Trial (PHITT)
Hepatoblastoma or hepatocellular carcinoma
The patient will be approached with the option of joining the trial early in the diagnosis. The patient will be asked to confirm their consent to participate in the trial and for a sample of their tumour to be sent for research purposes. An assessment will be made to categorise the level of disease (called PRETEXT staging) using the age, AFP level, presence of metastases and tumour location. The level of disease will be categorised according to analysis by Children's Hepatic tumour International Collaboration (CHIC) - Hepatoblastoma Stratification. If appropriate, the patient will be asked to consent to receive treatment. The patient will be allocated to one of six different treatment groups, depending on their disease: Group A: Very Low Risk Hepatoblastoma (HB) The results from the Central Pathology review of the patient's tumour tissue will be used to determine if the patient should receive cisplatin treatment or no treatment. If the tumour shows "WDF" histology, the patient receives no treatment and is seen at routine visits for follow up assessment only. If the tumour shows "non-WDF" histology, the patient receives a dose of cisplatin on Day 1 of two 21 day cycles. Group B: Low Risk Hepatoblastoma These patients will receive a dose of Cisplatin on Day 1 of two 14 day cycles. The patient is then assessed for surgery to remove the tumour by the Consultant working on the study. If surgery is carried out, the patient is randomised to one of the following two arms: 1. Patient receives cycle 3 and cycle 4 of Cisplatin treatment or 2. Patient receives cycles 4-6 of Cisplatin treatment. If surgery is not feasible after cycle 1 and cycle 2, the patient receives cycles 3 and 4 of Cisplatin treatment and is re-assessed for surgery. If surgery is still not feasible, the patient receives cycles 5 and 6 of Cisplatin treatment. Group C: Intermediate Risk Hepatoblastoma These patients will be randomised to receive one of the following three treatments. 1. SIOPEL3HR: A
1. Clinical diagnosis of HB and histologically defined diagnosis of HB or HCC 2. Aged 0-30 years 3. Written informed consent for trial entry
1. Any previous chemotherapy or currently receiving anti-cancer agents 2. Recurrent disease 3. Previously received a solid organ transplant 4. Uncontrolled infection 5. Unable to follow the protocol for any reason 6. Second malignancy 7. Pregnant or breastfeeding women