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Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

Primary Purpose

Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

Status
Completed
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, Portal vein tumor thrombus

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)
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
  • Cirrhotic status of Child Pugh class A or B7
  • Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
  • Patient or guardian must be able to provide verbal and written informed consent

Exclusion Criteria:

  • Prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
  • Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
  • Uncontrolled inter-current illness except liver cirrhosis

Sites / Locations

  • Gyeongsang National University Hospital
  • Dongnam Institute of Radiological & Medical Sciences
  • Keimyung University Dongsan Medical Center
  • Catholic University Incheon St. Mary's Hospital
  • Inha University Hospital
  • Seoul National 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 HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)

Outcomes

Primary Outcome Measures

Tumor stabilization rate
Tumor stabilization rate was based on the combined number of patients with complete response(CR), partial response(PR), and stable disease(SD) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Secondary Outcome Measures

Overall survival
From the date of SABR to the date of death or last follow-up
Tumor progression free survival
From the date of SABR to the date of first failure 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
May 2, 2013
Last Updated
September 18, 2019
Sponsor
Korea Cancer Center Hospital
Collaborators
Seoul National University Hospital, Dongnam Institute of Radiological & Medical Sciences, Soon Chun Hyang University, Inha University Hospital, Incheon St.Mary's Hospital, Gyeongsang National University Hospital, Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01850368
Brief Title
Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
Official Title
Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea Cancer Center Hospital
Collaborators
Seoul National University Hospital, Dongnam Institute of Radiological & Medical Sciences, Soon Chun Hyang University, Inha University Hospital, Incheon St.Mary's Hospital, Gyeongsang National University Hospital, Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Recently, several studies reported promising outcomes of patients after external beam radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis. However, conventional EBRT is composed of many fractions (20-35 fractions). On the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. SABR increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with major portal vein tumor thrombosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
Keywords
Hepatocellular carcinoma, Stereotactic ablative radiotherapy, Stereotactic body radiotherapy, Portal vein tumor thrombus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stereotactic ablative radiotherapy
Arm Type
Experimental
Arm Description
Stereotactic ablative radiotherapy for HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
Intervention Type
Radiation
Intervention Name(s)
Stereotactic ablative radiotherapy
Other Intervention Name(s)
Stereotactic body radiotherapy
Intervention Description
The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by >48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 19.2 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 > 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy.
Primary Outcome Measure Information:
Title
Tumor stabilization rate
Description
Tumor stabilization rate was based on the combined number of patients with complete response(CR), partial response(PR), and stable disease(SD) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
From the date of SABR to the date of death or last follow-up
Time Frame
6 months, 1 year and 2 year
Title
Tumor progression free survival
Description
From the date of SABR to the date of first failure or last follow-up
Time Frame
6 months, 1 year and 2 year
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
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) Eastern Cooperative Oncology Group performance status 0 or 1 HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) Cirrhotic status of Child Pugh class A or B7 Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months. Patient or guardian must be able to provide verbal and written informed consent Exclusion Criteria: Prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy) Uncontrolled inter-current illness except liver cirrhosis
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
Gyeongsang National University Hospital
City
Jinju
State/Province
Gyeongsang-nam-do
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Name
Dongnam Institute of Radiological & Medical Sciences
City
Busan
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
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
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
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
Citations:
PubMed Identifier
21621346
Citation
Yoon SM, Lim YS, Won HJ, Kim JH, Kim KM, Lee HC, Chung YH, Lee YS, Lee SG, Park JH, Suh DJ. Radiotherapy plus transarterial chemoembolization for hepatocellular carcinoma invading the portal vein: long-term patient outcomes. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):2004-11. doi: 10.1016/j.ijrobp.2011.03.019. Epub 2011 May 27.
Results Reference
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PubMed Identifier
21696524
Citation
Kim JY, Chung SM, Choi BO, Kay CS. Hepatocellular carcinoma with portal vein tumor thrombosis: Improved treatment outcomes with external beam radiation therapy. Hepatol Res. 2011 Sep;41(9):813-24. doi: 10.1111/j.1872-034X.2011.00826.x. Epub 2011 Jun 22.
Results Reference
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PubMed Identifier
8799408
Citation
Tanaka A, Morimoto T, Yamaoka Y. Implications of surgical treatment for advanced hepatocellular carcinoma with tumor thrombi in the portal vein. Hepatogastroenterology. 1996 May-Jun;43(9):637-43.
Results Reference
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PubMed Identifier
22570179
Citation
Kang JK, Kim MS, Cho CK, Yang KM, Yoo HJ, Kim JH, Bae SH, Jung DH, Kim KB, Lee DH, Han CJ, Kim J, Park SC, Kim YH. Stereotactic body radiation therapy for inoperable hepatocellular carcinoma as a local salvage treatment after incomplete transarterial chemoembolization. Cancer. 2012 Nov 1;118(21):5424-31. doi: 10.1002/cncr.27533. Epub 2012 May 8.
Results Reference
background
PubMed Identifier
23547075
Citation
Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.
Results Reference
background
PubMed Identifier
21645977
Citation
Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
Results Reference
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Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

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