Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of Hepatocellular Carcinoma (HCC)
NCT ID: NCT01381211
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
72 participants
INTERVENTIONAL
2011-09-30
2020-03-31
Brief Summary
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For patients with disease confined to the liver, but locally more advanced, transarterial treatment modalities are proposed. These therapies exploit the dual blood supply to the liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver parenchyma derives \> 75% of its blood supply from the portal vein. Antitumoral agents, such as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.
Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads (TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.
TACE is currently the gold standard for treatment of patients with intermediate stage HCC, with a reported median survival of around 17 months. A novel development in the TACE treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is substantially higher compared to conventional TACE.
Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which implements transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.
In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel treatments that both have theoretical and/or proven advantages compared to the use of conventional TACE, in patients with intermediate stage HCC.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Yttrium-90 radioembolization (90Y-RE)
90Y-RE
Glass Yttrium-90 microspheres (TheraSphere®; MDS Nordion Inc.) will be used
Transarterial chemoembolization with drug eluting beads
Transarterial chemoembolization is performed with drug eluting beads, polyvinyl alcohol-based microspheres (DC Beads, Biocompatibles) loaded with the chemotherapeutic agent doxorubicin.
TACE-DEB
Transcatheter arterial chemoembolization (TACE) is performed with drug eluting beads (DEB), polyvinyl alcohol-based microspheres loaded with the chemotherapeutic agent doxorubicin.
Interventions
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TACE-DEB
Transcatheter arterial chemoembolization (TACE) is performed with drug eluting beads (DEB), polyvinyl alcohol-based microspheres loaded with the chemotherapeutic agent doxorubicin.
90Y-RE
Glass Yttrium-90 microspheres (TheraSphere®; MDS Nordion Inc.) will be used
Eligibility Criteria
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Inclusion Criteria
* The diagnosis HCC is confirmed by typical appearance on imaging or cytohistological evaluation (liver biopsy).
* Accurate staging:
MRI of the liver CT-scan of the abdomen and thorax bone scintigraphy, only in case of clinical symptoms suggestive of skeletal metastases.
Exclusion Criteria
* Pregnancy or breastfeeding
* Age under 18 years
* Child-Pugh score \>B7
* ECOG performance status (PST) \> 1
* Bilirubin \> 2.6 mg/dl
* AST/ALT \>5x upper limit of normal (ULN)
* \>50% of liver involvement
* Main portal vein (right, left or common trunk) thrombosis
* Extra-hepatic disease
* Previous treatment of study target lesions
* 99mTc-labelled macroaggregated albumin (99mTc-MAA) scintigraphy shows lack of MAA uptake in tumor (photopenic lesion)
* Activity \> 610 MBq and activity reduction would imply a liver target dose \> 80 Gy
* patients who are declared incompetent or suffering from physic disorders that make a comprehensive judgement impossible, such as psychosis.
* Unmanageable intolerance for contrast medium
* Life expectancy \< 3 months or otherwise impossible follow-up
* Inadequate bone marrow, liver and/or renal function
* other contraindications to hepatic embolization procedures.
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Luc Defreyne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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References
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Dhondt E, Lambert B, Hermie L, Huyck L, Vanlangenhove P, Geerts A, Verhelst X, Aerts M, Vanlander A, Berrevoet F, Troisi RI, Van Vlierberghe H, Defreyne L. 90Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial. Radiology. 2022 Jun;303(3):699-710. doi: 10.1148/radiol.211806. Epub 2022 Mar 8.
Seinstra BA, Defreyne L, Lambert B, Lam MG, Verkooijen HM, van Erpecum KJ, van Hoek B, van Erkel AR, Coenraad MJ, Al Younis I, van Vlierberghe H, van den Bosch MA. Transarterial radioembolization versus chemoembolization for the treatment of hepatocellular carcinoma (TRACE): study protocol for a randomized controlled trial. Trials. 2012 Aug 23;13:144. doi: 10.1186/1745-6215-13-144.
Other Identifiers
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2011/050
Identifier Type: -
Identifier Source: org_study_id