Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment stereotactic ablative radiotherapy
Phase phase 2
Sponsor Korea Cancer Center Hospital
Collaborator Dongnam Institute of Radiological & Medical Sciences
Start date June 2012
End date June 2015
Trial size 54 participants
Trial identifier NCT01825824, K-1205-001-005, KCT0000454, KROG 12-02

Summary

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 ablative radiotherapy (SABR) alone or with TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.

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
Arm
(Experimental)
Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization
stereotactic ablative radiotherapy Stereotactic body radiotherapy
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 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. Dose of esophagus, stomach and intestine do not exceed 30 Gy.

Primary Outcomes

Measure
Local control rate
time frame: up to 1 year

Secondary Outcomes

Measure
Overall survival rate
time frame: up to 2 years
Progression free survival rate
time frame: up to 2 years
Intrahepatic recurrence free survival rate
time frame: up to 2 years
Treatment related toxicity
time frame: up to 1 year

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 - 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 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 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

Additional Information

Official title Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm
Principal investigator Mi-Sook Kim, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Korea Cancer Center Hospital.