RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

University of Alabama at Birmingham1 site in 1 country5 target enrollmentNovember 2009

ConditionsHepatocellular Carcinoma Liver Cancer

InterventionsSorafenib Stereotactic Body Radiotherapy (SBRT)

DrugsSorafenib

Overview

Phase: N/A
Intervention: Sorafenib
Conditions: Hepatocellular Carcinoma
Sponsor: University of Alabama at Birmingham
Enrollment: 5
Locations: 1
Primary Endpoint: Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug in patients with hepatocellular carcinoma.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

June 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Dr. Kimberly Keene

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

•Child-Pugh class A or B7 cirrhosis.
•No prior radiation therapy to the upper right abdominal quadrant.
•Size of each tumor less than 6 cm.
•Three or less known lesions.
•More than 800 cc of uninvolved liver.
•Age \> 19 years old
•ECOG Performance Status 0 or 1
•Adequate bone marrow, liver and renal function as assessed by the following:
•Hemoglobin \> 8.5 g/dl
•Platelet count \> 50,000/mm3

Exclusion Criteria

•Child-Pugh class B8 or C cirrhosis.
•ECOG greater than or equal to
•Uncontrolled ascites despite medical management.
•Less than 800 cc of uninvolved liver.
•Prior radiotherapy to the upper abdominal quadrant.
•Prior antiangiogenic or tyrosine kinase inhibitor therapy Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina(anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
•Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
•Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
•Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management.
•Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.

Arms & Interventions

Radiation followed by Sorafenib

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Intervention: Sorafenib

Radiation followed by Sorafenib

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Intervention: Stereotactic Body Radiotherapy (SBRT)

Outcomes

Primary Outcomes

Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma

Time Frame: between baseline and 3 years

Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib

Secondary Outcomes

The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume(baseline, 4 weeks and 10 weeks)
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).(baseline, 4 weeks and 10 weeks)
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.(baseline, 4 weeks after baseline and 10 weeks post baseline)
The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).(baseline, 4 weeks post baseline, 10 weeks post baseline)