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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01918683
• Collaborator: Loyola University (Other), Oregon Health and Science University (Other)
• Enrollment: 40
• Locations: 3
• Arms: 2
• Duration (Months): 173
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Radiation: TACE transarterial chemoembolization; Radiation: stereotatic body radiotherapy (SBRT)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: two armstwo arms
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
• Study Start Date: Jul 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: A -Tace alone A - TACE alone (control group, current practice and treatment)	Radiation: TACE transarterial chemoembolization
Experimental: B - Tace combined with SBRT B- TACE combined with SBRT (experimental group).	Radiation: TACE transarterial chemoembolization; Radiation: stereotatic body radiotherapy (SBRT)

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [10 days]

   endpoint is OLT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center	Maywood	Illinois	United States	60153
2	Oregon Health & Science University	Portland	Oregon	United States	97239
3	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania
• Loyola University
• Oregon Health and Science University

Investigators

• Principal Investigator: Edgar Ben-Josef, MD, Abramson Cancer Center of the University of Pennsylvania
• Principal Investigator: Tarita Thomas, MD, PhD, Loyola University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01918683
• Other Study ID Numbers: UPCC 16213
• First Posted: Aug 8, 2013
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Dec 6, 2021