NCT03960008

Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant

A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Lahey Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.

Detailed description

For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.

Conditions

• Hepatocellular Carcinoma
• HCC

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.
PROCEDURE	Trans-Arterial Chemoembolization (TACE)	First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation
DRUG	Doxorubin	This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2019-05-22
• Last updated: 2024-08-28
• Results posted: 2024-08-28

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study