TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients

Conditions:Liver Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:July 2013
End Date:July 2019
Contact:Edgar Ben-Josef, MD

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A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation

This trial is designed to be the initial prospective pilot investigation of the effectiveness
of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation.
No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant
population have been performed. We propose the trial be conducted as a pilot clinical trial
with the goal of enrolling 40 patients into each arm

The purpose of this study is to determine whether the combination of stereotatic body
radiotherapy (SBRT) tand transarterial chemoembolization (TACE) is an effective "bridging
therapy" for patients hepatocellular carcinoma (HCC) of the liver awaiting transplantation.

Inclusion Criteria:

- Patient capable of giving informed consent

- Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed
for orthotopic liver transplantation at the participating institution

- Age > 18 years old

- Meets clinical criteria for eligibility for TACE to the target lesion per
Interventional Radiology

- Childs' Class A or B7

- Eastern Clinical Oncology Group performance status 0 or 1

Exclusion Criteria:

- Prior radiotherapy to the upper abdomen or radioembolization of the liver

- Prior TACE to the target lesion, RFA, or liver transplant

- Active GI bleed within 2 weeks of study enrollment

- Active GI ulcer disease within 4 weeks of study enrollment

- Ascites refractory to medical therapy

- Contraindication to receiving radiotherapy or TACE

- Complete obstruction of portal venous flow to the segment of liver that includes the
target lesion

- Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable
to undergo follow-up imaging or SBRT treatment planning)

- Women who are pregnant

- Participation in another concurrent treatment protocol
We found this trial at
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Tarita Thomas, MD
Phone: 708-216-2568
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
Maywood, IL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-418-3247
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Portland, OR
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Edgar Ben-Josef, MD
Phone: 877-204-9213
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
Philadelphia, PA
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