Paediatric hepatic international tumour trial

Paediatric Hepatic International Tumour Trial (PHITT)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17869351

Enrollment

450

Registered

2017-04-24

Start date

2017-08-25

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatoblastoma or hepatocellular carcinoma Cancer Malignant neoplasm of liver and intrahepatic bile ducts

Interventions

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 tum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Event-free survival (EFS) is measured as the time from randomisation (or registration into the trial for non-randomised patients) to first failure event or last follow-up date 2. Response in HCC is measured using RECIST version 1.1 criteria, after 3 cycles of PLADO, or 4 cycles of PLADO+S/GEMOX+S in Group F 3. Best Response is measured using RECIST version 1.1 criteria and AFP decline at end of treatment for Groups A, B, C, D and E	—

Measure

Time frame

1. Event-free survival (EFS) is measured as the time from randomisation (or registration into the trial for non-randomised patients) to first failure event or last follow-up date 2. Response in HCC is measured using RECIST version 1.1 criteria, after 3 cycles of PLADO, or 4 cycles of PLADO+S/GEMOX+S in Group F 3. Best Response is measured using RECIST version 1.1 criteria and AFP decline at end of treatment for Groups A, B, C, D and E

—

Secondary

Measure	Time frame
1. Overall survival (OS) is measured as the time from randomisation (or registration for non-randomised patients) to death from any cause 2. Toxicity is measured using Common Terminology Criteria for Adverse Events (CTCAE), at the end of each cycle of treatment 3. Hearing loss is measured using SIOP Boston Scale for oto-toxicity at end of treatment and follow up 4. Surgical resectability is measured using surgical outcome during treatment after surgery 5. Adherence to surgical guidelines is measured using the current SIOPEL surgical guidelines and the local clinician’s surgical decision to resect after surgical assessment	—

Measure

Time frame

1. Overall survival (OS) is measured as the time from randomisation (or registration for non-randomised patients) to death from any cause 2. Toxicity is measured using Common Terminology Criteria for Adverse Events (CTCAE), at the end of each cycle of treatment 3. Hearing loss is measured using SIOP Boston Scale for oto-toxicity at end of treatment and follow up 4. Surgical resectability is measured using surgical outcome during treatment after surgery 5. Adherence to surgical guidelines is measured using the current SIOPEL surgical guidelines and the local clinician’s surgical decision to resect after surgical assessment

—

Countries

Austria, Belgium, Czech Republic, England, Finland, France, Germany, Ireland, Israel, Netherlands, Northern Ireland, Norway, Scotland, Spain, Switzerland, United Kingdom, Wales

Contacts

Public ContactSteve Baker

phitt@trials.bham.ac.uk+44 121 415 1061

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026