Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060556) titled 'A Prospective REgistry study of Stereotactic body radioTherapy for hepatOcellular carcinoma' on March 1.

Study Type: Observational

Primary Sponsor: Institute - Kochi University

Condition: Condition - Hepatocellular carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study will prospectively register cases of stereotactic body radiotherapy (SBRT) for small hepatocellular carcinoma (HCC) treated at multiple institutions nationwide, evaluate the therapeutic efficacy and safety of SBRT, and clarify the actual treatment conditions in real-world settings. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old =100 Gy, delivered in 8 fractions or fewer) is feasible. 6) Written informed consent for trial participation has been obtained from the patient. Key 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. Target Size - 600

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 18 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2035 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066841

Disclaimer: Curated by HT Syndication.