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Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Stereotactic ablative radiotherapy
Sponsored by
Korea Cancer Center Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Stereotactic ablative radiotherapy, Stereotactic body radiotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic ablative radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Local control rate
From the date of SABR to the date of local failure or last follow-up

Secondary Outcome Measures

Overall survival rate
From the date of SABR to the date of death or last follow-up
Progression free survival rate
From the date of SABR to the date of first failure or last follow-up
Intrahepatic recurrence free survival rate
From the date of SABR to the date of Intrahepatic recurrence or last follow-up
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

Full Information

First Posted
April 3, 2013
Last Updated
September 18, 2019
Sponsor
Korea Cancer Center Hospital
Collaborators
Dongnam Institute of Radiological & Medical Sciences, Soonchunhyang University Hospital, Inje University, Inha University Hospital, Incheon St.Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01825824
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea Cancer Center Hospital
Collaborators
Dongnam Institute of Radiological & Medical Sciences, Soonchunhyang University Hospital, Inje University, Inha University Hospital, Incheon St.Mary's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Stereotactic ablative radiotherapy, Stereotactic body radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic ablative radiotherapy
Arm Type
Experimental
Arm Description
Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization
Intervention Type
Radiation
Intervention Name(s)
Stereotactic ablative radiotherapy
Other Intervention Name(s)
Stereotactic body radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local control rate
Description
From the date of SABR to the date of local failure or last follow-up
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
From the date of SABR to the date of death or last follow-up
Time Frame
up to 2 years
Title
Progression free survival rate
Description
From the date of SABR to the date of first failure or last follow-up
Time Frame
up to 2 years
Title
Intrahepatic recurrence free survival rate
Description
From the date of SABR to the date of Intrahepatic recurrence or last follow-up
Time Frame
up to 2 years
Title
Treatment related toxicity
Description
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
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi-Sook Kim, MD, PhD
Organizational Affiliation
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of
Facility Name
Dongnam Institute of Radiological & Medical Sciences
City
Busan
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
Country
Korea, Republic of
Facility Name
Catholic University Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
City
Seoul
ZIP/Postal Code
139-706
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Seoul
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

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