This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment stereotactic body radiotherapy
Phase phase 2
Sponsor Korea Cancer Center Hospital
Collaborator Dongnam Institute of Radiological & Medical Sciences
Start date January 2012
End date April 2015
Trial size 71 participants
Trial identifier NCT01850667, K-1201-001-004, KCT0000454


The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic body radiotherapy (SBRT) alone or with TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%. They reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible. In addition, they found that the presence of gastroduodenal ulcer before SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study, we will conduct a multicenter phase II trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Stereotactic body radiotherapy for unresectable hepatocellular carcinoma after incomplete trans-arterial chemo-embolization
stereotactic body radiotherapy Stereotactic ablative radiotherapy
Total stereotactic Body radiotherapy (SBRT) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by >48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 17 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of > 17 Gy. In patients without gastroduodenal ulcer on Esophagogastroduodenoscopy (EGD) before SBRT, D2ml of gastrointestinal tract should not exceed 35 Gy. In patients with gastroduodenal ulcer on EGD before SBRT, D2ml of gastrointestinal tract should exceed 28 Gy. (D2ml: minimum dose to 2 ml of gastrointestinal tract)

Primary Outcomes

Treatment related toxicity-free survival
time frame: 1 year

Secondary Outcomes

Overall survival
time frame: 2 years
Progression free survival
time frame: 2 years
Intrahepatic recurrence free survival
time frame: 2 years
Patterns of failure
time frame: 2 years
Systemic failure free survival
time frame: 2 years
Local control rate
time frame: 2 years

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Male or female patients ≥ 20 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 700 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

Additional Information

Official title Phase II Multicenter Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Toxicity and Outcome
Principal investigator Mi-Sook Kim, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Korea Cancer Center Hospital.