Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01825824
• Other study ID #: K-1205-001-005
• Secondary ID: KCT0000454KROG 1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: June 2020

Study information

• Verified date: September 2019
• Source: Korea Cancer Center Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: June 2020
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Stereotactic ablative 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.

Locations

Country	Name	City	State
Korea, Republic of	Dongnam Institute of Radiological & Medical Sciences	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Catholic University Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Korea Cancer Center Hospital	Dongnam Institute of Radiological & Medical Sciences, Incheon St.Mary's Hospital, Inha University Hospital, Inje University, Soonchunhyang University Cheonan Hospital, Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate	From the date of SABR to the date of local failure or last follow-up	up to 1 year
Secondary	Overall survival rate	From the date of SABR to the date of death or last follow-up	up to 2 years
Secondary	Progression free survival rate	From the date of SABR to the date of first failure or last follow-up	up to 2 years
Secondary	Intrahepatic recurrence free survival rate	From the date of SABR to the date of Intrahepatic recurrence or last follow-up	up to 2 years
Secondary	Treatment related toxicity	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	up to 1 year