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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

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Trial Information

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


Inclusion Criteria:



- Male or female patients ≥18 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor stabilization rate

Outcome 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.

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Mi-Sook Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Korea: Ministry of Food and Drug Safety

Study ID:

K-1209-001-007

NCT ID:

NCT01850368

Start Date:

October 2012

Completion Date:

May 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Portal Vein Tumor Thrombus
  • Hepatocellular carcinoma
  • Stereotactic ablative radiotherapy
  • Stereotactic body radiotherapy
  • Portal vein tumor thrombus
  • Carcinoma
  • Thrombosis
  • Carcinoma, Hepatocellular

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