Transarterial Chemoembolization Versus Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Summary

Rationale:

This study will compare head to head in patients with hepatocellular carcinoma (HCC) ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic body radiation therapy (SBRT). The investigators hypothesis is that the time to progression is more favorable after SBRT than after TACE-DEB. The expected time to include the required patients for this trial will be four years.

To the best of the investigators knowledge this study will be the first in the world that will compare both techniques in a randomized trial.

Objective:

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

Study design:

Randomized, prospective, open-label, and phase II study.

Study population:

Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤ 6cm, and ≥ 18 years old.

Intervention:

Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with doxorubicin or the experimental arm, SBRT.

Main study parameters/endpoints:

The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression.

Secondary endpoints will be:

* Time to local recurrence
* Response rate (complete and partial response)
* Overall survival
* Toxicity
* Quality of life.

Conditions

• Liver Neoplasms

Interventions

RADIATION

Radiation therapy

6 fractions of 8-9Gy

DEVICE

chemoembolization

Up to 4 sessions

Sponsors & Collaborators

• Dutch Cancer Society

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• VU University of Amsterdam

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Maastro Clinic, The Netherlands

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Alejandra Mendez Romero, MD PhD · Erasmus Medical Center

• Adriaan Moelker, MD PhD · Erasmus Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2020-04-30

Completion

2020-04-30

Countries

• Belgium
• France
• Netherlands

Study Locations