Hepatoblastoma with distant metastasis at diagnosis (high-risk hepatoblastoma)1
Conditions
Interventions
According to SIOPEL4 protocol, after administration of preoperative chemotherapy consisting of 3 blocks chemotherapy of weekly cisplatin (CDDP) and doxorubicin (DOX), surgical resection is performed a
Sponsors
Japanese Study Group for Pediatiric Liver Tumor (JPLT)
Grants-in-aid for Scientific Research, Ministry for Education, Culture, Sports, Science and technology-JAPAN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed newly diagnosed hepatoblastoma or Primary liver tumor with high levels of serum AFP 2) high risk hepatoblastoma: by international risk stratification 3) any PRETEXT with M1 (distant metastasis) or N2 (distant lymph-node metastasis) 4) or Serum alpha-fetoprotein (AFP) < 100 ng/ml 5) Definition of lung metastasis: one nodule is larger than 1 cm or several nodules with one lesion ( > 5mm) 6) Age <= 18 years and >=1 month 7) No previous chemotherapy, surgery, radiotherapy for this disease 8) Written informed consent and national/local ethics committee and regulatory approval 9) Ability to comply with requirements for submission of material for central review (radiology, pathology and biology) 10) No severe organ failure: the cases who will be alive for more than 3 months 1PS: Karnofsky/Lansky performance status>30 2White cell counts > 2000/micro L 3ALT <= 300IU/L and T.Bil < 2.0 mg/dl But, the cases whose total bilirubin levels increased by physiological (constitutional or neonatal) icterus are excluded. 4Creatinine clearance by 24 hours urine or estimated GFR calculated by Schwartz formula > 70mL/min/1.73 m2 5No cardiac diseases requiring treatments 11) No active infections 12) Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained 13) Females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method
Exclusion criteria
Exclusion criteria: Cases with one or more following factors 1) rhabdoid tumor 2) Hepatocellular carcinoma 3) Treatments was started at more than 15 days after the report of biopsy or 4) Cases who will be unable to be alive for more than 3 months 5) Abnormal renal function defined as GFR < 50% of the lower limit of normal for age, which over 2 years of age is < 70 ml/min/1.73 m2 at diagnosis 6) Abnormal heart function (initial EF < 50% or SF < 28%) 7) Active double cancers 8) Recurrent diseases 9) Female under pregnancy 10) Patient unable to undergo chemotherapy by poor general condition, complications or abnormalities 11) Case whose approval to register this trail is refused 12) Patients unable to the protocol for any reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicities and these percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate at the end of therapy Response rate of pre-operative chemotherapy Percentage of surgical complications Accomplishment rate Pathohistological evaluation of preoerative chemothearapy genetic analysis(cases with approval) banking (cases with approval) | — |
Countries
Japan
Contacts
Public ContactSho Kurihara
Hiroshima University Hospital Pediatric Surgery
Outcome results
None listed