hepatoblastoma
Conditions
Interventions
4 cycles with cisplatin (CDDP) and doxorubicin (DOX) (PLADO) therapy which are administered with 3 weeks duration. In each cycle,CCDP DIV for 24 hours 80 mg/m2/day on Day 1.DOX IV for 24 hours 30 mg/
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 Intermediate risk hepatoblastoma: by international risk stratification PRETEXT I, II or III Serum alpha-fetoprotein (AFP) > 100 micro-g/L with additional PRETEXT criteria and no distant metastasis (M, N3 factors) 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 Standard risk hepatoblastoma: Serum - Alpha-fetoprotein (AFP) <=100 micro-g/L Distant metastases, any site (M1) Lymph node metastases (N1, N2) Tumor involving all 4 hepatic sections or PRETEXT I, II, or III without Additional PRETEXT factors (Extrahepatic abdominal disease (E1, E1a, E2, E2a), Intraperitoneal hemorrhage or tumour rupture (H1), 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 |
|---|---|
| Response rate to neo-adjuvant chemotherapy The correlation with therapeutic choice by the efficacy of neo-adjuvant chemotherapy and outcome of the patient (Intermediate risk) 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