Spots Global Cancer Trial Database for Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
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Trial Identification
Brief Title: Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
Official Title: A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)
Study ID: NCT01887717
Conditions
Study Description
Brief Summary: This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of participants with inoperable liver cancer and blockage of the portal vein.
Detailed Description: The objective of this Phase III, prospective randomized trial is to determine whether TheraSphere provides a meaningful benefit in survival in comparison with the standard of care (sorafenib) in participants with good hepatic function and advanced hepatocellular carcinoma (HCC) associated with portal vein thrombosis (PVT). This is an open-label prospective, multi-center, randomized, controlled clinical trial that will evaluate the use of TheraSphere compared to standard-of-care sorafenib alone.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwestern Medical Faculty Foundation, Div of Hematology/Oncology, Chicago, Illinois, United States
Mount Sinai School of Medicine, New York, New York, United States
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Paoli-Calmettes Institute, Marseille, , France
UO Radiologia, Ospedali Riuniti di Bergamo, Bergamo, , Italy
Azienda Ospedaliero-Universitaria di Bologna, Bologna, , Italy
ASO-Santa Croce e Carle di Cuneo, Cuneo, , Italy
Fondazione IRCCS Ca Grande, Milano, , Italy
S.C Radiologia Interventistica, A.O.Ospedale Niguarda Ca Granda, Milano, , Italy
Fondazione Istituto Nazionale Tumori di Milano, Milano, , Italy
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello", Palermo, , Italy
University of Pisa, Pisa, , Italy
Policlinico A. Gemelli, Rome, , Italy
Hospital Clínic Barcelona. IDIBAPS. CIBEREHD. Liver Unit, Barcelona, , Spain
Bulevar Sur s/n, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Gastroenterology & Hepatology Dept, Madrid, , Spain
Hospital Universitari i Politecnic la Fe, Valencia, , Spain
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Royal Free London NHS Foundation Trust, London, , United Kingdom
Contact Details
Name: Vincenzo Mazzaferro, MD
Affiliation: Istituto Tumori Nazionale, Milan, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Riad Salem, MD
Affiliation: Northwestern University Chicago Illinois
Role: PRINCIPAL_INVESTIGATOR
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