Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

NCT01850368 | Completed Phase 2

• 3 other identifiers: K-1209-001-007KCT0000542KROG 13-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 8

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.

Conditions

Hepatocellular Carcinoma; Portal Vein Tumor Thrombus

Keywords

Hepatocellular carcinoma; Stereotactic ablative radiotherapy; Stereotactic body radiotherapy; Portal vein tumor thrombus

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (3)

• Overall survival

  6 months, 1 year and 2 year

• Tumor progression free survival

  6 months, 1 year and 2 year

• Treatment related toxicity

  1 year

Study Arms (1)

Stereotactic ablative radiotherapy

EXPERIMENTAL

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)

Radiation: Stereotactic ablative radiotherapy

Interventions

Stereotactic ablative radiotherapy RADIATION

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.

Also known as: Stereotactic body radiotherapy

Stereotactic ablative radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Cancer Center Hospital: lead
• Seoul National University Hospital: collaborator
• Dongnam Institute of Radiological & Medical Sciences: collaborator
• Soon Chun Hyang University: collaborator
• Inha University Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• Gyeongsang National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (8)

Gyeongsang National University Hospital

Jinju, Gyeongsang-nam-do, 660-702, South Korea

Location

Dongnam Institute of Radiological & Medical Sciences

Busan, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Catholic University Incheon St. Mary's Hospital

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

Seoul, 139-706, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Location

Related Publications (6)

• 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.

  PMID: 21621346 BACKGROUND

• 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.

  PMID: 21696524 BACKGROUND

• 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.

  PMID: 8799408 BACKGROUND

• 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.

  PMID: 22570179 BACKGROUND

• 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.

  PMID: 23547075 BACKGROUND

• 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.

  PMID: 21645977 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mi-Sook Kim, MD, PhD

  Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 9, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2017
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

KR (8)