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

NCT02958163 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-11-07

No results posted yet for this study

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.

Conditions

  • Liver Neoplasms
  • Hepatocellular 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.

Sponsors & Collaborators

  • Erasme University Hospital

    collaborator OTHER

  • Jules Bordet Institute

    collaborator OTHER

  • University of Liege

    collaborator OTHER

  • Clinique Saint Joseph, Liège

    collaborator OTHER

  • Centre Hospitalier Universitaire UCLouvain Namur

    collaborator OTHER

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Xavier GEETS · Cliniques Universitaires Saint Luc/MIRO

  • Ivan BORBATH · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2017-10-17
Completion
2017-10-17

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958163 on ClinicalTrials.gov