Clinical trial NCT01850368: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Keywords: Hepatocellular carcinoma
Stereotactic ablative radiotherapy
Stereotactic body radiotherapy
Portal vein tumor thrombus
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Dongnam Institute of Radiological & Medical Sciences
name: Soon Chun Hyang University
name: Inha University Hospital
name: Incheon St.Mary's Hospital
name: Gyeongsang National University Hospital
name: Keimyung University Dongsan Medical Center
First posted: 2013-05-09
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tumor stabilization rate
timeFrame: 2 months
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months, 1 year and 2 year
measure: Tumor progression free survival
timeFrame: 6 months, 1 year and 2 year
measure: Treatment related toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsang-nam-do
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological & Medical Sciences
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Incheon
country: Korea, Republic of
facility: Catholic University Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
Study officials:
affiliation: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
name: Mi-Sook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.