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Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Inclusion Criteria:

- Male or female patients ≥ 18 years of age

- Initially diagnosed or recurrent hepatocellular carcinoma (HCC)

- Unresectable HCC

- Cirrhotic status of Child Pugh class A or B7

- Eastern Cooperative Oncology Group performance status 0 or 1

- single or sum of multiple tumor ≤ 5 cm

- HCC with 3 cm apart from gastrointestinal tract

- The volume of uninvolved must be at least 1000 ml

- Incomplete response after trans-arterial chemo-embolization of 1-5

- A single lesion or multiple lesions including portal vein tumor thrombosis included
in radiation field with one or consecutive sessions of stereotactic body radiation
therapy (SBRT)

- No evidence of an uncontrolled lesion at any other site

- No evidence of complications of liver cirrhosis

- No evidence of uncontrolled inter-current illness

- Patient or guardian must be able to provide verbal and written informed consent

Exclusion Criteria:

- Patient with previous history of abdominal radiation

- Direct invasion to esophagus, stomach or colon by HCC

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local control rate

Outcome Description:

From the date of SABR to the date of local failure or last follow-up

Outcome Time Frame:

up to 1 year

Safety Issue:


Principal Investigator

Mi-Sook Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences


Republic of Korea: Ministry of Food and Drug Safety

Study ID:




Start Date:

June 2012

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • Stereotactic ablative radiotherapy
  • Stereotactic body radiotherapy
  • Carcinoma
  • Carcinoma, Hepatocellular