Spots Global Cancer Trial Database for FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
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Trial Identification
Brief Title: FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Official Title: Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study
Study ID: NCT01721954
Conditions
Study Description
Brief Summary: This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. 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 Investigator.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Orlando Health, Orlando, Florida, United States
Memorial Healthcare, Pembroke Pines, Florida, United States
University of Illinois Chicago, Chicago, Illinois, United States
Adventist Midwest Health, Hinsdale, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Center, Buffalo, New York, United States
Lenox Hill Hospital, New York, New York, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Spartanburg Regional Healthcare / Gibbs Cancer Center, Spartanburg, South Carolina, United States
Methodist Hospital Dallas, Dallas, Texas, United States
St. Mark's Hospital, Salt Lake City, Utah, United States
Fletcher Allen Health Care, Burlington, Vermont, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Gosford Hospital, Gosford, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Royal Brisbane Hospital, Herston, Queensland, Australia
Gold Coast Health Services District, Southport, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Hobart Hospital, Hobart, Tasmania, Australia
Monash Medical Centre, Bentleigh East, Victoria, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Western Hospital, Footscray, Victoria, Australia
Peninsula Oncology Centre, Frankston, Victoria, Australia
South Eastern Hospital, Noble Park, Victoria, Australia
Maroondah Hospital, Ringwood East, Victoria, Australia
St. John of God Murdoch Hospital, Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
OL Vrouw Ziekenhuis, Aalst, , Belgium
Institut Jules Bordet, Brussels, , Belgium
University of Antwerp, Edegem, , Belgium
Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie, Gent, , Belgium
AZ Maria Middelaress, Gent, , Belgium
CHU Sart Tilman, Liege, , Belgium
CHU Amiens, Amiens Cedex 1, , France
Centre Hospitalier General de Longjumeau, Clichy Cedex, , France
Hopital Beaujon, Clichy Cedex, , France
Hopital Albert Michallon - Grenoble, Grenoble Cedex 9, , France
Hopital Europeen Georges Pompidou, Paris, , France
CHU de Bordeaux - Hopital Saint Andre, Pessac, , France
CHU de Poitiers, Pole regional de cancerologie, Poitiers cedex, , France
Centre Eugene Marquis, Rennes Cedex, , France
Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie, Berlin, , Germany
SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie, Heilbronn, , Germany
Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin, Karlsruhe, , Germany
Schwerpunktpraxix fur Hamatologie und Onkologie, Magdeburg, , Germany
Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin, Magdeburg, , Germany
Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie, Magdeburg, , Germany
Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie, Marburg, , Germany
St. Franziskus Hospital Muenster, Muenster, , Germany
Klinikum rechts der Isar der TU Munchen Medizinische Klinik II, Munchen, , Germany
Klinikum der Universitat Munchen, Munich, , Germany
Rambam Medical Center, Haifa, , Israel
Shaare-Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
TA Sourasky Medical Center, Oncology Department 6, Tel Aviv, , Israel
Sheba Medical Center - Governmental Hospital - Oncology Division, Tel Hashomer, , Israel
Ospedale Regionale U. Parini, Aosta, , Italy
Dipartimento di Oncologia, Ospendali Riuniti di Bergamo, Bergamo, , Italy
A.O.U. die Bologna, Bologna, , Italy
Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo, Cuneo, , Italy
U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello, Pisa, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Wellington Hospital, Newtown, Wellington, New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Auckland University, Grafton, , New Zealand
Regional Cancer Treatment Service, Palmerston North, , New Zealand
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E., Porto, , Portugal
National Cancer Centre Singapore, Singapore, , Singapore
Hospital Universitario Puerta de Hierro Majadahonda, Madrid, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
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