ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01918683
Recruitment Status : Recruiting
First Posted : August 8, 2013
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
Loyola University
Oregon Health and Science University
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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 Within Milan Criteria for Liver Tranplantation Radiation: TACE transarterial chemoembolization Radiation: stereotatic body radiotherapy (SBRT) Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 40 participants
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 : July 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 10 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918683


Contacts
Contact: Edgar Ben-Josef, MD 877-204-9213 PennCancerTrials@emergingmed.com

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Beth Chiappetta, RN    708-216-2568    BCHIAPPETTA@lumc.edu   
Principal Investigator: Tarita Thomas, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: John Minger    503-418-3247    mingerj@ohsu.edu   
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Edgar Ben-Josef, MD    877-204-9213    PennCancerTrials@emergingmed.com   
Principal Investigator: Edgar Ben-Josef, MD         
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

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01918683     History of Changes
Other Study ID Numbers: UPCC 16213
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases