530
Participants
Start Date
August 31, 2006
Primary Completion Date
May 31, 2015
Study Completion Date
May 31, 2015
SIR-Spheres yttrium-90 microspheres
"SIR-Spheres microspheres (yttrium-90 \[Y-90\] labelled resin microspheres), hepatic artery injection administered on Day 3 or 4 of cycle 1.~mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.~Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.~In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2."
Systemic chemotherapy (FOLFOX)
"mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.~Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.~In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2."
Charite Campus Virchow Klinikum, Berlin
St. Vincent's Hospital, Darlinghurst
ZNA Middelheim, Antwerp
Royal North Shore Hospital, St Leonards
Sydney Adventist Hospital, Wahroonga
Concord Hospital, Concord
Westmead Hospital, Westmead
St. George Hospital, Kogarah
Sint-Augustinus Ziekenhuis, Wilrijk
VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel, Mechelen
Imelda Ziekenhuis GI Clinical Research Centre, Bonheiden
AZ Heilige Familie, Reet
Sint-Josef Ziekenhuie (Campus Bornem), Bornem
UZ Leuven, Campus Gasthuisberg, Leuven
Western Hospital, Footscray
Royal Melbourne Hospital, Parkville
John Fawkner Private Hospital, Coburg
Ringwood/Knox Private, Ringwood
Maroondah Public, Ringwood East
South Eastern Private, Noble Park
Peninsula Oncology Centre, Frankston
Royal Brisbane and Women's Hospital, Herston
Wesley Medical Centre, Auchenflower
Gold Coast Health Service District, Southport
HOCA Gold Coast Centre, Southport
Cairns Private Hospital, Cairns
Lyell McEwin Hospital, Elizabeth Vale
Mount Medical Centre, Perth
Hollywood Private Hospital, Nedlands
Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie, Frankfurt
Royal Hobart Hospital, Hobart
Hospital de Jolimont, Haine-Saint-Paul
Hospital European Georges Pompidou, Paris
Universiteits Ziekenhuis Gent, Ghent
OL Vrouw Ziekenhuis Aalst Gastro-Enterologie, Aalst
Montefiore Medical Center, The Bronx
University of Pittsburgh Medical Center, Pittsburgh
Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin, Hamburg
University of Maryland Medical Center, Baltimore
Carolinas Hematology-Oncology Associates, Charlotte
Carolinas Medical Center, Charlotte
Clinica Universitaria de Navarra, Pamplona
Hospital de Navarra, Servicio de Ongoligia, Planta Baja, Pamplona
CHU de Bordeau, Bordeaux
Florida International University College of Medicine Practice, North Miami Beach
Universitatsklinikum GieBen und Marburg, Marburg
Hospitalier Universitaire de Grenoble C.H.U., La Tronche
Schwerpunktpraxis fur Hamatologie und Onkologie, Magdeburg
Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie, Magdeburg
A.O.U. die Bologna, Bologna
University of Louisville, Louisville
Praxis fur Hamatologie und Internnistische Onkologie, Velbert
Kliniken Essen Mitte, Essen
William Beaumont Hospital, Royal Oak
Rabin Medical Center, Beilinson Hospital, Petah Tikva
Sheba Medical Center, Ramat Gan
Braxiskooperation Bonn, Fachartze fur Innere Medizin, Bonn
Aurora St. Luke's Medical Center, Milwaukee
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital, Milwaukee
Virginia Piper Cancer Institute, Minneapolis
Altru Health Systems, Grand Forks
Vanguard Health, Berwyn
Adventist Hinsdale Hospital, Hinsdale
University of Illinois at Chicago, Chicago
TA Sourasky Medical Center, Tel Aviv
Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik, Karlsruhe
Ingalls Memorial Hospital, Harvey
Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl, Holzkirch
Internistische Gemeinschaftspraxis, Altstadt
St. Mark's Hospital, Salt Lake City
Onklogische Praxis Dr. Gerald Gehbauer, Ingolstadt
Pinnacle Oncology Hematology, Scottsdale
City of Hope Hospital, Duarte
Shaare-Zedek Medical Centre, Jerusalem
Centre Hospitalier General de Longjumeau, Longjumeau
University of Washington, Seattle
Holy Name Hospital, Teaneck
Nepean Cancer Care Centre, Kingswood
Princess Alexandra Hospital, Woolloongabba
Royal Adelaide Hospital, Adelaide
Ashford Cancer Centre, Ashford
Flinders Medical Centre, Bedford Park
Queen Elizabeth II Hospital, Woodville South
Monash Medical Centre, Bentleigh East
Sir Charles Gairdner Hospital, Nedlands
Royal Perth Hospital, Perth
Antwerp University Hospital, Antwerp
Institut Jules Bordet - Centre de Tumeurs d'ULB, Brussels
AZ Maria Middelares, Ghent
Centre Hospitalier Universitaire de Liege, Liège
Centre Eugene Marquis, Rennes
Johanniterkrankenhaus Bonn, Bonn
Universitaetsklinikum Bonn, Bonn
Gemeinschaftspraxis Hamatologie und internistische Onkologie, Essen
Universitastsklinikum Saarland, Hamburg
Universitaetsklinikum Magdeburg, Magdeburg
Hamato-Onkologische Schwerpunktspraxis, München
Klinikum Bogenhausen, München
Klinikum der Universitaet Muenchen, München
Klinikum rechts der Isar der TU Munchen, München
Schwerpunktspraxis fur Hamatologie und Internistische Onkologie, München
Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr, Weilheim
Rambam Medical Center, Haifa
University of Auckland, Auckland
Christchurch Hospital, Christchurch
Dunedin Hospital, Dunedin
Wellington Hospital, Newtown
Palmerston North Hospital, Palmerston
Hopital de l'Archet II, CHU de Nice, Nice
Wojskowy Instytut Medyczny (WIM), Warsaw
Universitatsspital Zurich, Zurich
Lead Sponsor
Sirtex Medical
INDUSTRY