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Open Access Study protocol

Transarterial RAdioembolization versus ChemoEmbolization for the treatment of hepatocellular carcinoma (TRACE): study protocol for a randomized controlled trial

Beatrijs A Seinstra1, Luc Defreyne4, Bieke Lambert5, MarnixGEHH Lam3, Helena M Verkooijen1, Karel J van Erpecum2, Bart van Hoek9, Arian R van Erkel7, Minneke J Coenraad8, Imad Al Younis9, Hans van Vlierberghe6 and MauriceAAJ van den Bosch1*

Author Affiliations

1 Department of Radiology, University Medical Center Utrecht, Room E.01.132, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands

2 Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands

3 Department of Nuclear Medicine, University Medical Center Utrecht, Utrecht, The Netherlands

4 Department of Vascular and Interventional Radiology, Ghent University Hospital, Ghent, Belgium

5 Department of Nuclear Medicine, Ghent University Hospital, Ghent, Belgium

6 Department of Gastroenterology and Hepatology, Ghent University Hospital, Ghent, Belgium

7 Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands

8 Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands

9 Department of Nuclear Medicine, Leiden University Medical Center, Leiden, The Netherlands

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Trials 2012, 13:144  doi:10.1186/1745-6215-13-144

Published: 23 August 2012

Abstract

Background

Hepatocellular carcinoma is a primary malignant tumor of the liver that accounts for an important health problem worldwide. Only 10 to 15% of hepatocellular carcinoma patients are suitable candidates for treatment with curative intent, such as hepatic resection and liver transplantation. A majority of patients have locally advanced, liver restricted disease (Barcelona Clinic Liver Cancer (BCLC) staging system intermediate stage). Transarterial loco regional treatment modalities offer palliative treatment options for these patients; transarterial chemoembolization (TACE) is the current standard treatment. During TACE, a catheter is advanced into the branches of the hepatic artery supplying the tumor, and a combination of embolic material and chemotherapeutics is delivered through the catheter directly into the tumor. Yttrium-90 radioembolization (90Y-RE) involves the transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor. 90Y-RE is increasingly used in clinical practice for treatment of intermediate stage hepatocellular carcinoma, but its efficacy has never been prospectively compared to that of the standard treatment (TACE). In this study, we describe the protocol of a multicenter randomized controlled trial aimed at comparing the effectiveness of TACE and 90Y-RE for treatment of patients with unresectable (BCLC intermediate stage) hepatocellular carcinoma.

Methods/design

In this pragmatic randomized controlled trial, 140 patients with unresectable (BCLC intermediate stage) hepatocellular carcinoma, with Eastern Cooperative Oncology Group performance status 0 to 1 and Child-Pugh A to B will be randomly assigned to either 90Y-RE or TACE with drug eluting beads. Patients assigned to 90Y-RE will first receive a diagnostic angiography, followed by the actual transarterial treatment, which can be divided into two sessions in case of bilobar disease. Patients assigned to TACE will receive a maximum of three consecutive transarterial treatment sessions. Patients will undergo structural follow-up for a timeframe of two years post treatment. Post procedural magnetic resonance imaging (MRI) will be performed at one and three months post trial entry and at three-monthly intervals thereafter for two years to assess tumor response. Primary outcome will be time to progression. Secondary outcomes will be overall survival, tumor response according to the modified RECIST criteria, toxicities/adverse events, treatment related effect on total liver function, quality of life, treatment-related costs and cost-effectiveness.

Trial registration

NCT01381211