Hepatocellular carcinoma
Conditions
Interventions
None listed
Sponsors
Kochi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases treated with SBRT at JROSG-participating facilities or JASTRO-certified facilities that meet the following criteria are eligible. 1) Liver function: Child-Pugh class A or B. 2) Primary or recurrent HCC. Prior treatment for recurrent HCC may include surgery, TACE, percutaneous therapy, or SBRT at a different site. 3) Tumor size of 3 cm or less in total with no more than 3 lesions, or a single lesion of 5 cm or less. In cases of multiple lesions where SBRT is performed on only part of the lesions, the remaining lesions must undergo curative RFA or surgery. Other radiation therapy for other lesions (excluding those described in item 5 below) is not permitted. 4) Pathologically diagnosed as HCC, or demonstrating typical HCC contrast-enhancing findings on abdominal contrast-enhanced CT (dynamic CT for the liver), abdominal contrast-enhanced MRI (dynamic MRI), or Sonazoid US, characterized by high contrast enhancement in the early phase and low contrast enhancement in the late phase. 5) Cases where SBRT (with a central dose or maximum dose of BED10 >=100 Gy, delivered in 8 fractions or fewer) is feasible. 6) Written informed consent for trial participation has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Tumor embolization in major branches of the portal vein, hepatic vein, or bile duct (Vp3, 4, Vv2, 3, B3, 4) (3.3.2.1. Vascular invasion/bile duct invasion). 2) Lymph node metastasis or distant metastasis is present. 3) Previous radiation therapy to the same site with concerns about safety for adjacent critical organs. 4) Previous registration in this study. 5) Esophageal varices requiring treatment. 6) Active infection (excluding HBV/HCV). 7) Active concurrent cancer (including synchronous and metachronous cancers with a disease-free interval of 3 years or less). However, the following are excluded from active concurrent cancer: carcinoma in situ deemed curable by local therapy; lesions equivalent to intraepithelial or mucosal cancer; WHO classification T1N0M0 laryngeal cancer (glottic origin); localized prostate cancer; stage I breast cancer; and cancers with an expected prognosis equivalent to these. 8) Concurrent mental illness or psychiatric symptoms that make participation in this trial or follow-up observation difficult. 9) Pregnancy or possibility of pregnancy. 10) History of systemic drug therapy for HCC. 11) Other conditions deemed inappropriate for participation in this trial by the responsible physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, 3-year overall survival rate, progression-free survival, 5 years (3 years) progression-free survival rate, , local disease-free survival, 5 years (3 years) local disease-free survival rate, 5 years (3 years) local control rate, intrahepatic disease-free survival, 5 years (3 years) intrahepatic disease recurrence rate, extrahepatic (lymph node + distant) metastasis-free survival period, 5-year (3-year) extrahepatic (lymph node + distant) metastasis recurrence rate, disease-specific survival period, 5-year (3-year) disease-specific survival rate, 5-year (3-year) liver failure mortality rate, 5-year (3 years) Liver-related survival rate (including both primary disease death and liver failure death as events), incidence of adverse events, incidence of Grade 2 or 3 or higher adverse events, proportion of patients with worsening liver function (Child-Pugh 2 or higher), treatment for first recurrence | — |
Countries
Japan
Contacts
Public ContactNaoko Sanuki
Keio University Hospital Department of Radiation Oncology
Outcome results
None listed