Paediatric hepatic international tumour trial
Phase 3
- Conditions
- Hepatoblastoma or hepatocellular carcinomaCancerMalignant neoplasm of liver and intrahepatic bile ducts
- Registration Number
- ISRCTN17869351
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 450
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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<br>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 Outcome Measures
Name Time Method 1. Overall survival (OS) is measured as the time from randomisation (or registration for non-randomised patients) to death from any cause<br>2. Toxicity is measured using Common Terminology Criteria for Adverse Events (CTCAE), at the end of each cycle of treatment<br>3. Hearing loss is measured using SIOP Boston Scale for oto-toxicity at end of treatment and follow up<br>4. Surgical resectability is measured using surgical outcome during treatment after surgery<br>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