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Multicenter Phase II study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma =5 cm

Multicenter Phase II study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma =5 cm

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0000454
Enrollment
54
Registered
2012-06-07
Start date
2012-06-11
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : The HCC patients with size =5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 60 Gy in 3 fractio

Sponsors

Korea Institute of Radiological & Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female patients =18 years of age 2. Intitially diagnosed or recurrent hepatocellular carcinoma (HCC) 3. Unresectable HCC 4. Cirrhotic status of Child Pugh class A or B7 5. Eastern Cooerative Oncology Group performance status 0 or 1 6. single or sum of multiple tumor =5 cm 7. HCC with 3 cm apart from gastrointestinal tract 8. The volume of uninvolved must be at least 1000 ml 9. Incomplete response after trans-arterial chemo-embolization of 1-5 10. A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sesseions of SBRT 11. No evidence of an uncontrolled lesion at any other site 12. No evidence of complications of liver cirrhosis 13. No evidence of uncontrolled inter-current illness 14. Patient or gaurdian must be able to provide verbal and written informed consent

Exclusion criteria

Exclusion criteria: 1. Patient with previous history of abdominal radiation 2. Direc invasion to esophagus, stomach or colon by HCC

Design outcomes

Primary

MeasureTime frame
Local control rate

Secondary

MeasureTime frame
Overall survival rate;Progression free survival rate;Intrahepatic recurrence free survival rate;treatment related toxicity

Countries

Korea, Republic of

Contacts

Public ContactSun Hyun Bae

Korea Institute of Radiological & Medical Sciences

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026