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

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status

Active, not recruiting

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: stereotatic body radiotherapy (SBRT)
Radiation: TACE transarterial chemoembolization

Study type

Interventional

Funder types

Other

Identifiers

NCT01918683
UPCC 16213

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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