Clinical trial NCT01825824: Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm
Official title: Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Stereotactic ablative radiotherapy
Stereotactic body radiotherapy
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
Collaborators: name: Dongnam Institute of Radiological & Medical Sciences
name: Soonchunhyang University Hospital
name: Inje University
name: Inha University Hospital
name: Incheon St.Mary's Hospital
First posted: 2013-04-08
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Local control rate
timeFrame: up to 1 year
Secondary outcomes:
measure: Overall survival rate
timeFrame: up to 2 years
measure: Progression free survival rate
timeFrame: up to 2 years
measure: Intrahepatic recurrence free survival rate
timeFrame: up to 2 years
measure: Treatment related toxicity
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological & Medical Sciences
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Incheon
country: Korea, Republic of
facility: Catholic University Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
Study officials:
affiliation: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
name: Mi-Sook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: