Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Overview

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.

Full Title of Study: “Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Stereotactic ablative radiotherapy
    • Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization

Clinical Trial Outcome Measures

Primary Measures

  • Local control rate
    • Time Frame: up to 1 year
    • From the date of SABR to the date of local failure or last follow-up

Secondary Measures

  • Overall survival rate
    • Time Frame: up to 2 years
    • From the date of SABR to the date of death or last follow-up
  • Progression free survival rate
    • Time Frame: up to 2 years
    • From the date of SABR to the date of first failure or last follow-up
  • Intrahepatic recurrence free survival rate
    • Time Frame: up to 2 years
    • From the date of SABR to the date of Intrahepatic recurrence or last follow-up
  • Treatment related toxicity
    • Time Frame: up to 1 year
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korea Cancer Center Hospital
  • Collaborator
    • Dongnam Institute of Radiological & Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mi-Sook Kim, Doctor – Korea Cancer Center Hospital
  • Overall Official(s)
    • Mi-Sook Kim, MD, PhD, Principal Investigator, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

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