Overview

This trial is active, not recruiting.

Conditions hepatocellular carcinoma, portal vein tumor thrombus
Treatment stereotactic ablative radiotherapy
Phase phase 2
Sponsor Korea Cancer Center Hospital
Collaborator Seoul National University Hospital
Start date October 2012
End date July 2015
Trial size 28 participants
Trial identifier NCT01850368, K-1209-001-007, KCT0000542, KROG 13-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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)
stereotactic ablative radiotherapy Stereotactic body radiotherapy
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 Outcomes

Measure
Tumor stabilization rate
time frame: 2 months

Secondary Outcomes

Measure
Overall survival
time frame: 6 months, 1 year and 2 year
Tumor progression free survival
time frame: 6 months, 1 year and 2 year
Treatment related toxicity
time frame: 1 year

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
Principal investigator Mi-Sook Kim, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Korea Cancer Center Hospital.