Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT04996914
NA

Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma

Sponsor: RWTH Aachen University

View on ClinicalTrials.gov

Summary

The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection or orthotopic liver transplant.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-01

Completion Date

2028-08-01

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

PROCEDURE

TACE

1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference.

RADIATION

SBRT

SBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged. Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy)