Standard risk hepatoblastoma
Conditions
Interventions
Cisplatin alone
Cisplatin + Sodium Thiosulphate
Sponsors
Japanese study group for pediatric liver tumors
Health, Labour and Welfare Ministry, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed newly diagnosed hepatoblastoma Standard risk hepatoblastoma Centre/country willing and able to organise audiometry at the minimum required quality Ability to comply with requirements for submission of material for central revieved For females of child-bearing potential, a negative pregnancy test prior to study treatment is required. Any patient who is of reproductive age should agree to use adequate contraception for the duration of the trial.
Exclusion criteria
Exclusion criteria: High risk hepatoblastoma Hepatocellular carcinoma Treatment starting more than 15 days from written biopsy report Abnormal renal function Any previous chemotherapy Recurrent disease Previous hypersensitivity to STS Patient unable to follow the protocol for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Brock grade 1 hearing loss determined after end of trial treatment or at an age of at least 3.5 years, whichever is later. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to preoperative chemotherapy Complete resection Complete remission Event free survival (EFS) Overall survival (OS) Toxicity as graded by CTCAE v 3.0 Long-term renal clearance Feasibility of central audiology review | — |
Countries
Japan,Asia(except Japan),Australia,Europe
Contacts
Public ContactSho Kurihara
Hiroshima University Hospital Pediatric Surgery
Outcome results
None listed