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NCT Number: NCT01850368

Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Portal Vein Tumor Thrombus

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gyeongsang National University Hospital, Jinju, Gyeongsang-nam-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Stereotactic body radiotherapy

Primary outcomes

  1. Tumor stabilization rate

    Time frame: 2 months

    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 outcomes

  1. Overall survival

    Time frame: 6 months, 1 year and 2 year

    From the date of SABR to the date of death or last follow-up

  2. Tumor progression free survival

    Time frame: 6 months, 1 year and 2 year

    From the date of SABR to the date of first failure or last follow-up

  3. Treatment related toxicity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Korea Cancer Center Hospital

Other

Collaborators

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

Registry information

Official study title

Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
May 9, 2013
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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