Know Cancer

forgot password

Phase II Multicenter Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Toxicity and Outcome

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

Thank you

Trial Information

Phase II Multicenter Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Toxicity and Outcome

Inclusion Criteria:

- Male or female patients ≥ 18 years of age

- Initially diagnosed or recurrent hepatocellular carcinoma (HCC)

- Unresectable HCC

- Inaccessible to local ablative treatment

- Cirrhotic status of Child Pugh class A or B7

- Eastern Cooperative Oncology Group performance status 0 or 1

- Tumor size < 10cm

- 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 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:

Treatment related toxicity-free survival

Outcome Description:

From the date of SBRT to the date of treatment related toxicity or last follow-up; Treatment related toxicity will be evaluated by the following criteria. Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Classic radiation induced liver disease; Non-classic Classic radiation induced liver disease; Worsening of Child-Turcotte-Pugh score; Worsening of MELD score

Outcome Time Frame:

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


Korea: Ministry of Food and Drug Safety

Study ID:




Start Date:

January 2012

Completion Date:

September 2015

Related Keywords:

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