Hepatocellular carcinoma
Conditions
Interventions
Carbon-ion radiotherapy consisting of two fractions of 48.0 Gy(RBE) in total or 4 fractions of 60.0 Gy(RBE) in total
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients clinically diagnosed as hepatocellular carcinoma with abdominal dynamic CT or MRI showing hyperdense lesion at early phase and hypodense at delayed phase, or those diagnosed with histopathology 2) Within three lesions of uncontrolled hepatocellular carcinoma 3) No extrahepatic lesion, except for lesion which can be treated within single field of irradiation such as lymph nodes at hepatic portal region or around celiac trunk 4) Measurable target lesion 5) No invasion of main portal vein, common bile duct or inferior vena cava 6) 20 years old or more at registration of this trial 7) 0 to 2 of ECOG performance status before registration 8) A or B of Child-Pugh classification (Score 9 or below) before registration 9) No ascites or pleural fluid which is difficult to treat 10) Fulfilled with all of the following criteria of clinical laboratory tests taken within 14 days before trial registration (a) Between 1,500 /mm3 or more, and, 10,000 /mm3 or less of white blood cell count (b) 30,000 /mm3 or more of platelet count (c) 7.0 g/dL or more of hemoglobin concentration (d) 3.0 mg/dL or less of total serum bilirubin 11) Expected improvement of survival or symptom after treatment in this trial 12) Not eligible for other clinical trials on carbon-ion radiotherapy in Kanagawa Cancer Center 13) Written consent obtained
Exclusion criteria
Exclusion criteria: 1) Patients who are expected within one year of survival even after treatment of hepatocellular carcinoma 2) Past history of radiotherapy for target lesion 3) Patients with gastroesophageal varix which should be treated 4) Patients with 38 C or more of fever at registration of this trial or with infection which requires systemic treatment 5) Pregnant, possibly pregnant, within 28 days after delivery or breast-feeding female 6) Patients who are difficult to be participated in this trail due to psychological diseases, intractable heart or lung diseases at registration 7) Patients who are not suitable to be participated due to medical reason evaluated by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year local control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Three-year overall survival 2) Three-year disease-specific survival 3) Adverse event rate 4) Incidence of 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