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Open Access Study protocol

Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial

Roman Kloeckner1*, Christian Ruckes2, Kai Kronfeld2, Marcus Alexander Wörns3, Arndt Weinmann3, Peter Robert Galle3, Hauke Lang4, Gerd Otto4, Waltraud Eichhorn5, Mathias Schreckenberger5, Christoph Dueber1 and Michael Bernhard Pitton1

Author Affiliations

1 Department of Diagnostic and Interventional Radiology, Johannes Gutenberg-University Medical Center, Langenbeckstr. 1, 55131 Mainz, Germany

2 Interdisciplinary Center for Clinical Trials (IZKS), Johannes Gutenberg-University Medical Center, Langenbeckstr.1, 55131 Mainz, Germany

3 First Department of Internal Medicine, Johannes Gutenberg-University Medical Center, Langenbeckstr.1, 55131 Mainz, Germany

4 Department of General and Transplant Surgery, Johannes Gutenberg-University Medical Center, Langenbeckstr.1, 55131 Mainz, Germany

5 Department of Nuclear Medicine, Johannes Gutenberg-University Medical Center, Langenbeckstr.1, 55131 Mainz, Germany

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Trials 2014, 15:311  doi:10.1186/1745-6215-15-311

Published: 6 August 2014

Abstract

Background

Cholangiocellular carcinoma is the second most common primary liver cancer after hepatocellular carcinoma. Over the last 30 years, the incidence of intrahepatic cholangiocellular carcinoma has risen continuously worldwide. Meanwhile, the intrahepatic cholangiocellular carcinoma has become more common than the extrahepatic growth type and currently accounts for 10-15% of all primary hepatic malignancies. Intrahepatic cholangiocellular carcinoma is typically diagnosed in advanced stages due to late clinical symptoms and an absence of classic risk factors. A late diagnosis precludes curative surgical resection. There is evidence that transarterial chemoembolization leads to better local tumor control and prolongs survival compared to systemic chemotherapy. New data indicates that selective internal radiotherapy, also referred to as radioembolization, provides promising results for treating intrahepatic cholangiocellular carcinoma.

Methods/Design

This pilot study is a randomized, controlled, single center, phase II trial. Twenty-four patients with intrahepatic cholangiocellular carcinoma will be randomized in a 1:1 ratio to receive either chemoembolization or radioembolization. Randomization will be stratified according to tumor load. Progression-free survival is the primary endpoint; overall survival and time to progression are secondary endpoints. To evaluate treatment success, patients will receive contrast enhanced magnetic resonance imaging every 3 months.

Discussion

Currently, chemoembolization is routinely performed in many centers instead of systemic chemotherapy for treating intrahepatic cholangiocellular carcinoma confined to the liver. Recently, radioembolization has been increasingly applied to cholangiocellular carcinoma as second line therapy after TACE failure or even as an alternative first line therapy. Nonetheless, no randomized studies have compared radioembolization and chemoembolization. Considering all this background information, we recognized a strong need for a randomized controlled trial (RCT) to compare the two treatments. Therefore, the present protocol describes the design of a RCT that compares SIRT and TACE as the first line therapy for inoperable CCC confined to the liver.

Trial registration

ClinicalTrials.gov, Identifier: NCT01798147, registered 16th of February 2013.

Keywords:
Intrahepatic cholangiocellular carcinoma (CCC); loco-regional treatment; selective internal radiotherapy (SIRT); transarterial chemoembolization (TACE)