HEpatocellular carcinoma stereotactic RAdiotherapy CLinical Evaluation Study

Recruiting

• Conditions: C22.0; Liver cell carcinoma

• Registration Number: DRKS00008566
• Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Histologically or cytologically confirmed hepatocellular carcinoma OR diagnosis made with characteristic enhancement in 4-Phase CT or MRI corresponding to AASLD- / EASL guidelines in cirrhotic patients; Discussion in a routine multidisciplinary tumour board; Understanding of procedure, significance and consequences of the study; given informed consent. SBRT Group: Patients unsuitable for surgery, TACE*, RFA, or alcohol ablation / *TACE patients will be recruited for control group; bilirubin has to be < 4 x the upper limit of normal, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin= 90 g/L, platelets = 50 x 10^9/L, and neutrophils = 1.0 x 10^9/L. TACE Group: Patients suitable for TACE; bilirubin has to be <2 mg/dL, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin= 90 g/L, platelets = 50 x 10^9/L, and neutrophils = 1.0 x 10^9/

Exclusion Criteria

Child-Turcotte-Pugh (CTP) C liver score; Hepatic encephalopathy more than Grade 1 according to Child Pugh criteria; Active hepatitis; Gastric, duodenal or variceal bleed within 2 months of registration; Prior radiotherapy of the region to be treated; For female patients: Pregnancy, planned pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility, i.e. recruitment and conduct of a prospective study using SBRT or TACE according to their standard medical indications

Secondary Outcome Measures

Name	Time	Method
Toxicity acute and late measured as NCI-CTCAE v4.0, progression free survival (PFS), overall survival (OS)