Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

February 20, 2017

Primary Completion Date

October 17, 2017

Study Completion Date

October 17, 2017

Conditions
Liver NeoplasmsHepatocellular Cancer
Interventions
PROCEDURE

Trans-arterial Chemo-Embolization

Trans-Arterial Chemo-Embolization will be performed with Doxorubicin-Eluting-Beads (DEB-TACE). It will be performed in each arm of treatment.

DRUG

Doxorubicin

Drug-eluting Bead for Trans Arterial Chemo-Embolization will be loaded with Doxorubicin.

RADIATION

Stereotactic Ablative Radiotherapy

"SABR schemes will be adapted according to the CP score and the vicinity of surrounding organs at risk. These are the different schemes proposed in this trial:~48Gy = 3x16Gy BED 124.8Gy ( α/β=10) 50Gy = 5x10Gy BED 100Gy ( α/β=10) 48Gy = 6x8Gy BED 86.4Gy ( α/β=10) 40Gy = 5x8Gy BED 72Gy ( α/β=10)~For patients with Child-Pugh (CP) A cirrhosis : the choice of the scheme will be left to each physician. The highest BED should be favored if dose constraints to the organs at risk are respected.~For patients with CP B cirrhosis : only the latter scheme will be allowed: 40Gy = 5x8Gy."

Trial Locations (5)

1000

Institut Jules Bordet/Hôpital Erasme, Brussels

1200

Cliniques Universitaires Saint Luc, Brussels

4000

Centre Hospitalier Universitaire/CHC Saint Joseph, Liège

5000

Clinique et Maternité Sainte Elisabeth/CHU Mont Godinne, Namur

7100

Hôpital de JOLIMONT, Jolimont

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasme University Hospital

OTHER

collaborator

Jules Bordet Institute

OTHER

collaborator

University of Liege

OTHER

collaborator

Clinique Saint Joseph, Liège

OTHER

collaborator

Centre Hospitalier Universitaire UCLouvain Namur

OTHER

lead

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER