Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Stereotactic ablative radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic ablative radiotherapy<br>Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization | Radiation: Stereotactic ablative radiotherapy<br>* 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.<br>* Other names: Stereotactic body radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | From the date of SABR to the date of local failure or last follow-up | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | From the date of SABR to the date of death or last follow-up | up to 2 years | 
| Progression free survival rate | From the date of SABR to the date of first failure or last follow-up | up to 2 years | 
| Intrahepatic recurrence free survival rate | From the date of SABR to the date of Intrahepatic recurrence or last follow-up | up to 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Stereotactic ablative radiotherapy, Stereotactic body radiotherapy