Clinical trial NCT01918683: TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients
Official title: A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Loyola University
name: Oregon Health and Science University
First posted: 2013-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Edgar Ben-Josef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loyola University
name: Tarita Thomas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: