NCT02958163

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

Randomized Controlled Phase II Trial Comparing Trans-Arterial Chemo-Embolization (TACE) With TACE Plus Stereotactic Ablative Radiotherapy (SABR) in Stage BCLC B Hepatocarcinoma (HepSTAR)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B. This trial will also include one substudy. This substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (MRI) results. Every patient participating to the trial can also participate to this substudy.

Detailed description

The patients will be randomized in 2 arms determining the treatment they will receive: Arm A: actual standard treatment = TACE Arm B: experimental arm = TACE + SABR

Conditions

• Liver Neoplasms
• Hepatocellular Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-10-17
• Completion: 2017-10-17
• First posted: 2016-11-08
• Last updated: 2017-11-07

Locations

5 sites across 1 country: Belgium