Spots Global Cancer Trial Database for FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
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Trial Identification
Brief Title: FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Official Title: Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
Study ID: NCT00724503
Study Description
Brief Summary: This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pinnacle Oncology Hematology, Scottsdale, Arizona, United States
City of Hope Hospital, Duarte, California, United States
Florida International University College of Medicine Practice, North Miami Beach, Florida, United States
Vanguard Health, Berwyn, Illinois, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Adventist Hinsdale Hospital, Hinsdale, Illinois, United States
University of Louisville, Louisville, Kentucky, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Holy Name Hospital, Teaneck, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Carolinas Hematology-Oncology Associates, Charlotte, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Altru Health Systems, Grand Forks, North Dakota, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
St. Mark's Hospital, Salt Lake City, Utah, United States
University of Washington, Seattle, Washington, United States
Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, United States
Concord Hospital, Concord, New South Wales, Australia
St. Vincent's Hospital, Darlinghurst, New South Wales, Australia
Nepean Cancer Care Centre, Kingswood, New South Wales, Australia
St. George Hospital, Kogarah, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Sydney Adventist Hospital, Wahroonga, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Wesley Medical Centre, Auchenflower, Queensland, Australia
Cairns Private Hospital, Cairns, Queensland, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Gold Coast Health Service District, Southport, Queensland, Australia
HOCA Gold Coast Centre, Southport, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Ashford Cancer Centre, Ashford, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia
Queen Elizabeth II Hospital, Woodville South, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Monash Medical Centre, Bentleigh East, Victoria, Australia
John Fawkner Private Hospital, Coburg, Victoria, Australia
Western Hospital, Footscray, Victoria, Australia
Peninsula Oncology Centre, Frankston, Victoria, Australia
South Eastern Private, Noble Park, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Maroondah Public, Ringwood East, Victoria, Australia
Ringwood/Knox Private, Ringwood, Victoria, Australia
Hollywood Private Hospital, Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Mount Medical Centre, Perth, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
OL Vrouw Ziekenhuis Aalst Gastro-Enterologie, Aalst, , Belgium
ZNA Middelheim, Antwerpen, , Belgium
Antwerp University Hospital, Antwerp, , Belgium
Imelda Ziekenhuis GI Clinical Research Centre, Bonheiden, , Belgium
Sint-Josef Ziekenhuie (Campus Bornem), Bornem, , Belgium
Institut Jules Bordet - Centre de Tumeurs d'ULB, Brussels, , Belgium
Universiteits Ziekenhuis Gent, Gent, , Belgium
AZ Maria Middelares, Gent, , Belgium
Hospital de Jolimont, Haine-Saint-Paul, , Belgium
UZ Leuven, Campus Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege, Liege, , Belgium
VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel, Mechelen, , Belgium
AZ Heilige Familie, Reet, , Belgium
Sint-Augustinus Ziekenhuis, Wilrijk, , Belgium
CHU de Bordeau, Bordeaux, , France
Hospitalier Universitaire de Grenoble C.H.U., La Tronche, , France
Centre Hospitalier General de Longjumeau, Longjumeau, , France
Hopital de l'Archet II, CHU de Nice, Nice, , France
Hospital European Georges Pompidou, Paris, , France
Centre Eugene Marquis, Rennes Cedex, , France
Internistische Gemeinschaftspraxis, Altstadt, , Germany
Charite Campus Virchow Klinikum, Berlin, , Germany
Braxiskooperation Bonn, Fachartze fur Innere Medizin, Bonn, , Germany
Johanniterkrankenhaus Bonn, Bonn, , Germany
Universitaetsklinikum Bonn, Bonn, , Germany
Kliniken Essen Mitte, Essen, , Germany
Gemeinschaftspraxis Hamatologie und internistische Onkologie, Essen, , Germany
Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie, Frankfurt, , Germany
Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin, Hamburg, , Germany
Universitastsklinikum Saarland, Hamburg, , Germany
Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl, Holzkirch, , Germany
Onklogische Praxis Dr. Gerald Gehbauer, Ingolstadt, , Germany
Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik, Karlsruhe, , Germany
Schwerpunktpraxis fur Hamatologie und Onkologie, Magdeburg, , Germany
Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie, Magdeburg, , Germany
Universitaetsklinikum Magdeburg, Magdeburg, , Germany
Universitatsklinikum GieBen und Marburg, Marburg, , Germany
Klinikum Bogenhausen, Muenchen, , Germany
Klinikum der Universitaet Muenchen, Muenchen, , Germany
Hamato-Onkologische Schwerpunktspraxis, Munchen, , Germany
Klinikum rechts der Isar der TU Munchen, Munchen, , Germany
Schwerpunktspraxis fur Hamatologie und Internistische Onkologie, Munchen, , Germany
Praxis fur Hamatologie und Internnistische Onkologie, Velbert, , Germany
Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr, Weilheim, , Germany
Rambam Medical Center, Haifa, , Israel
Shaare-Zedek Medical Centre, Jerusalem, , Israel
Rabin Medical Center, Beilinson Hospital, Petah Tiqva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
TA Sourasky Medical Center, Tel Aviv, , Israel
A.O.U. die Bologna, Bologna, , Italy
University of Auckland, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Wellington Hospital, Newtown, , New Zealand
Palmerston North Hospital, Palmerston, , New Zealand
Wojskowy Instytut Medyczny (WIM), Warsaw, , Poland
Clinica Universitaria de Navarra, Pamplona, , Spain
Hospital de Navarra, Servicio de Ongoligia, Planta Baja, Pamplona, , Spain
Universitatsspital Zurich, Zurich, , Switzerland
Contact Details
Name: Peter Gibbs, MD
Affiliation: Melbourne Health
Role: PRINCIPAL_INVESTIGATOR
Name: Guy van Hazel, MD
Affiliation: Mount Medical Centre
Role: PRINCIPAL_INVESTIGATOR
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