Hepatocellular carcinoma
Conditions
Interventions
Proton beam therapy A total dose of 66GyE (RBE=1.1) in 10 fractions (5 fractions/week) For tumors within 2cm of the ports hepatic or gastrointestinal tract, a total dose of 72.6 GyE (RBE=1.1) in 22
Sponsors
Department of Radiation Oncology, Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven or Radiologically diagnosed hepatocellular carcinoma (HCC) on dynamic CT or dynamic MRI within 28 days before registration 2) No prior treatment for HCC 3) Solitary HCC without extrahepatic lesions on chest and abdominal CT within 28 days before registration 4) Measurable tumor on dynamic CT or dynamic MRI within 28 days before registration and maximum tumor diameter <= 12 cm in the axial plane 5) Absence of invasion of the main trunk and/or major branches of the portal vein and the bile duct, or the inferior vena cava 6) No contact with the gastrointestinal tract 7) Unsuitable for resection or liver transplantation judged by a multidisciplinary meeting, prediction of severe deterioration in liver function after hepatic resection based on ICG R15, 99mTc-GSA scintigraphy, or CT volumetry 8) Unsuitable or difficult to undergo local ablative therapies judged by a multidisciplinary meeting 9) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2 within 14 days before registration 10) Liver function of Child-Pugh class A within 14 days before registration 11) Absence of uncontrolled pleural effusion or ascites within 28 days before registration 12) Vital organ functions (listed below) are preserved within 14 days before registration WBC count >= 1,500/mm3; hemoglobin level >= 7.0 g/dL; platelet count >= 30,000/mm3; total bilirubin <= 3.0 mg/dL; sGOT (AST) and sGPT (ALT) < 5.0 x upper limit of normal 13) Age 20-years old or over at the time of obtaining the consent form 14) Given written informed consent to this study
Exclusion criteria
Exclusion criteria: 1) With other malignancies (simultaneous double cancer and heterochronic double cancer with disease-free time within 5 years), excluding lesions equivalent to carcinoma-in-situ or submucosal carcinoma 2) With esophageal or gastric varices at high risk for rupture within 28 days before registration 3) With active infection requiring systemic therapy 4) With a fever of 38 degrees Celsius or more 5) With cardiac infarction or unstable angina within 6 months before registration 6) With interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema 7) Allergic to radiation 8) Considered that participation in this trial is difficult due to psychiatric symptoms or psychosis 9) Females who are pregnant, breast-feeding, within 28 days postpartum or have a possibility of conception 10) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) 3-year progression free survival rate 2) 3-year local control rate 3) incidence of adverse events 4) Incidence of radiation induced liver disease (RILD) | — |
Countries
Japan
Contacts
Public ContactNorio Katoh
Hokkaido University Hospital Department of Radiation Oncology
Outcome results
None listed