Hepatocellular Carcinoma
Conditions
Interventions
Carbon-ion radiotherapy (C-RT) A total dose of 48.0 Gy(RBE)/2Fr or 60.0 Gy(RBE)/4Fr will be administered. C-RT with 60Gy(RBE)/12Fr will be performed if the subject shows the distance equal to or less
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinically diagnosed as hepatocellular carcinoma (HCC) by dynamic CT or MRI, or histologically diagnosed HCC 2) No past history of radiotherapy for target lesion 3) Single lesion without extrahepatic lesions or HCC with controlled lesions except for the target 4) Measurable lesion on clinical image studies 5) No invasion for main trunk of the portal vein, common bile duct or inferior vena cava 6) 20 years or older of the age at informed consent 7) 0 or 2 of ECOG performance status 8) A or B of Child-Pugh Classification (Score 9 or below) 9) No pleural effusion or ascites which is not controlled 10) Clinical laboratory data is fulfilled with the following criteria (a) 1,500 /mm3 or higher and 10,000/mm3 or less of white blood cells on complete blood count (b) 30,000 /mm3 or higher of platelet count (c) 7.0 g/dL or higher of hemoglobin (d) 3.0 mg/dL or less of serum total bilirubin 11) Informed consent given with document
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Past history of radiotherapy for the target lesion 3) Patient with gastroesophageal varix should be treated 4) 38 degrees celsius or higher of fever, except for tumor fever, or infection which requires systemic therapy 5) Pregnant women, women who may become pregnant, women who deliver with 28 days or lactating women 6) Patient who is difficult to participate this study due to psychiatric condition, uncontrolled heart disease or severe pulmonary disease 7) Patient who is not suitable to participate this study in accordance with physician's examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control rate at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Disease-specific survival 2) Overall survival 3) Adverse event rate 4) Event rate for radiation induced liver disease (RILD) | — |
Countries
Japan
Contacts
Public ContactHiroyuki Katoh
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center
Outcome results
None listed