Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

September 18, 2019 updated by: Mi-Sook Kim, Korea Cancer Center Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-896
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of
        • Dongnam Institute of Radiological & Medical Sciences
      • Cheonan, Korea, Republic of
        • Soon Chun Hyang University Hospital Cheonan
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Catholic University Incheon St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Soon Chun Hyang University Hospital Seoul
      • Seoul, Korea, Republic of, 139-706
        • Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Stereotactic body radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate
Time Frame: up to 1 year
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
Time Frame: up to 2 years
From the date of SABR to the date of death or last follow-up
up to 2 years
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
up to 2 years
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
up to 2 years
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
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Cancer Center Hospital

Collaborators

Inje University
Soonchunhyang University Hospital
Incheon St.Mary's Hospital
Inha University Hospital
Dongnam Institute of Radiological & Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (ESTIMATE)

April 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-1205-001-005 (OTHER: Korea Institute of Radiological & Medical Science IRB)
  • KCT0000454 (Registry Identifier: Clinical Research Information Service)
  • KROG 12-02 (REGISTRY: Korean Radiation Ocology Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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