Abstract | BACKGROUND: 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.
|
Authors | Roman Kloeckner, Christian Ruckes, Kai Kronfeld, Marcus Alexander Wörns, Arndt Weinmann, Peter Robert Galle, Hauke Lang, Gerd Otto, Waltraud Eichhorn, Mathias Schreckenberger, Christoph Dueber, Michael Bernhard Pitton |
Journal | Trials
(Trials)
Vol. 15
Pg. 311
(Aug 06 2014)
ISSN: 1745-6215 [Electronic] England |
PMID | 25095718
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Topics |
- Bile Duct Neoplasms
(therapy)
- Bile Ducts, Intrahepatic
- Chemoembolization, Therapeutic
- Cholangiocarcinoma
(therapy)
- Clinical Protocols
- Humans
- Outcome Assessment, Health Care
- Research Design
|