hepatoblastoma
Conditions
Interventions
4 cycles with neo-adjuvant cisplatin, monotherapy which is administered for 24 hours with 2 weeks duration. However, 2.7 and 1.8 mg/kg of cisplatin is administered in the infants whose body weight is
5kg, respectively. After these 4 cycles, surgical resection is performed and 2 cycles of adjuvant chemotherapy.
Sponsors
Japan Children's Cancer Group (JCCG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed newly diagnosed hepatoblastoma or Primary liver tumor with high levels of serum AFP Standard risk hepatoblastoma: by international risk stratification PRETEXT I, II or III Serum alpha-fetoprotein (AFP) > 100 micro-g/L No additional PRETEXT criteria 2)Age <=18 years and >=1 month 3)No previous chemotherapy 4)Written informed consent and national/local ethics committee and regulatory approval 5)Ability to comply with requirements for submission of material for central review (radiology, pathology and biology) 6)No severe organ failure: the cases who will be alive for more than 3 months 7)No active infections 8)Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained 9)Females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method
Exclusion criteria
Exclusion criteria: Cases with one of the following factors 1)High and Intermediate risk hepatoblastoma: Serum alpha-fetoprotein (AFP) <=100 micro-g/L Tumor involving all 4 hepatic sections - PRETEXT IV Additional PRETEXT criteria Extrahepatic abdominal disease (E1, E1a, E2, E2a) Intraperitoneal hemorrhage or tumor rupture (H1) Distant metastases, any site (M1) Lymph node metastases (N1, N2) Involvement of the main portal vein (P2, P2a) Involvement of all three hepatic veins and/or the IVC (V3, V3a) 2)Hepatocellular carcinoma 3)Treatments was started at more than 15days after the report of biopsy or diagnosis 4)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 5)Any previous chemotherapy 6)Double cancer 7)Recurrent disease 8)Female under pregnancy 9)Patient unable to undergo chemotherapy 10)Patient unable to the protocol for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression free survival: 3-year PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Outworking rate of cis-platin (CDDP) monotherapeutic regimen Response rate to neo-adjuvant chemotherapy Complete resection rate Surgical complication rate Overall survival (OS) Graded toxicities by CTCAE v. 4.0 Evaluation of biological, imaging. pathological data for new risk stratification Identification of clinic-pathological risk factors Identification of biologicall risk factors Genetic analysis (only accepted cases) | — |
Countries
Japan
Contacts
Public ContactSho Kurihara
Hiroshima University Hospital Pediatric Surgery
Outcome results
None listed