- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01918683
TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients
January 16, 2024 updated by: Abramson Cancer Center at Penn Medicine
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A -Tace alone
A - TACE alone (control group, current practice and treatment)
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Experimental: B - Tace combined with SBRT
B- TACE combined with SBRT (experimental group).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: 10 days
|
endpoint is OLT
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tarita Thomas, MD, PhD, Loyola University
- Principal Investigator: Edgar Ben-Josef, MD, Abramson Cancer Center at Penn Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 7, 2013
First Submitted That Met QC Criteria
August 7, 2013
First Posted (Estimated)
August 8, 2013
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 16213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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