Spots Global Cancer Trial Database for A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
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Trial Identification
Brief Title: A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Official Title: An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas
Study ID: NCT04083235
Study Description
Brief Summary: The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Banner Health- MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic - Scottsdale, Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center, Bakersfield, California, United States
University of California- Irvine Health Cancer Cente, Costa Mesa, California, United States
City of Hope National Medical Center, Duarte, California, United States
University of California, Los Angeles (UCLA), Los Angeles, California, United States
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare, Orange, California, United States
University of California - Irvine Medical Center, Orange, California, United States
Torrance Memorial Physician Network Cancer Care, Redondo Beach, California, United States
Sutter Health Sacramento, Sacramento, California, United States
Presbyterian Intercommunity Hospital (PIH), Whittier, California, United States
UC Health Memorial Hospital, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Mount Sinai Medical Center of Florida, Inc., Miami Beach, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Florida Cancer Specialists - Fort Myers, Sarasota, Florida, United States
Florida Cancer Specialists - Panhandle, Tallahassee, Florida, United States
Florida Cancer Specialists - St. Petersburg, Tampa, Florida, United States
Florida Cancer Specialists - East, West Palm Beach, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Edward Hospital - Elmhurst, Elmhurst, Illinois, United States
Illinois CancerCare - Peoria, Peoria, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Siouxland Hematology - Oncology Associates, LLP, Sioux City, Iowa, United States
University of Kentucky Markey Cancer Center, Lexington, Kentucky, United States
Pikeville Medical Center, Pikeville, Kentucky, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Willis-Knighton Cancer Center, Shreveport, Louisiana, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
Maryland Oncology Hematology, Silver Spring, Maryland, United States
Beth Israel Deaconess, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Health Partners Institute, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Research Medical Center, Kansas City, Missouri, United States
Frontier Cancer Center, Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Clinical Research Alliance, Inc, Lake Success, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Messino Cancer Center, Asheville, North Carolina, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James), Columbus, Ohio, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
University of Oklahoma - Health Sciences Center, Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon, Eugene, Oregon, United States
Compass Oncology - Rose Quarter Cancer Center, Portland, Oregon, United States
Kaiser Permanente - Northwest, Portland, Oregon, United States
Oregon Health & Science University (OHSU), Portland, Oregon, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Greenville Hospital System, Greenville, South Carolina, United States
Chattanooga Oncology Hematology Care - Tennessee Oncology, Chattanooga, Tennessee, United States
The West Cancer Center, Memphis, Tennessee, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
Texas Oncology - Austin, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Houston Methodist Research Institute, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Oncology Consultants, Houston, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Texas Oncology - Wichita Falls, Wichita Falls, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Blue Ridge Cancer Care, Wytheville, Virginia, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital, Bankstown, , Australia
Monash Medical Centre, Clayton, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
St John of God Subiaco Hospital, Subiaco, , Australia
Queen Elizabeth Hospital, Woodville South, , Australia
Medizinische Universitaet Graz, Graz, , Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, , Austria
SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh, Salzburg, , Austria
Medical University of Vienna, Vienna, , Austria
Onze-Lieve-Vrouwziekenhuis, Aalst, , Belgium
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen (UZA), Edegem, , Belgium
University Hospital Gent, Gent, , Belgium
Hospital centre Jolimont, Haine-Saint-Paul, , Belgium
University Hospital (UZ) Leuven, Leuven, , Belgium
University Hospital Mont-Godinne, Yvoir, , Belgium
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, , Brazil
Centro Regional Integrado de Oncologia (CRIO), Ceara, , Brazil
Instituto de Oncologia do Parana - IOP, Curitiba, , Brazil
Centro de Pesquisas Oncológicas - CEPON, Florianópolis, , Brazil
Hospital de Caridade de Ijui, Ijuí, , Brazil
Clinica Neoplasias Litoral, Itajaí, , Brazil
Hospital Bruno Born, Lajeado, , Brazil
Centro de Pesquisas Clinicas de Natal - CPCLIN, Natal, , Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Instituto Nacional Do Cancer (INCA), Rio de Janeiro, , Brazil
Instituto COI, Rio De Janeiro, , Brazil
Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo), San Paolo, , Brazil
CIP Centro Integrado de Pesquisas do Hospital de Base, São José Do Rio Preto, , Brazil
Hospital Alemão Oswaldo Cruz, São Paulo, , Brazil
Instituto do Cancer do Estado de São Paulo (ICESP), São Paulo, , Brazil
Alberta Health Services Cross Cancer Institute, Edmonton, , Canada
Queen Elizabeth II Health Sciences Centre, Halifax, , Canada
McGill University Faculty of Medicine - Royal Victoria Hospital, Montréal, , Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, , Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Králové, , Czechia
University Hospital Olomouc, Department of Oncology, Olomouc, , Czechia
Thomayerova Nemocnice, Praha, , Czechia
CHRU de Tours - Hôpital Trousseau, Chambray-lès-Tours, , France
Centre Oscar Lambret, Lille, , France
Hôpital Edouard Herriot, Lyon, , France
Centre Leon Berard, Lyon, , France
Hopital Prive Jean Mermoz, Lyon, , France
Centre Antoine-Lacassagne, Nice, , France
Hopital Saint Louis, Paris, , France
CHU Bordeaux - Hopital Haut-Leveque, Pessac, , France
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital, Poitiers Cedex, , France
Strasbourg Oncologie Liberale, Strasbourg, , France
Charité - Universitaetsmedizin Berlin, Berlin, , Germany
St. Josef-Hospital, Bochum, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
Studiengesellschaft BSF, Halle, , Germany
Martin Luther Universitat Halle-Wittenberg, Halle, , Germany
Facharztzentrum Eppendorf, Hamburg, , Germany
Marienkrankenhaus Hamburg, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Slk-Kliniken, Heilbronn, , Germany
Klinikum Mannheim, Mannheim, , Germany
Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH, Mönchengladbach, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Agios Savvas Anticancer Hospital, Athens, , Greece
General Hospital of Athens - Laiko, Athens, , Greece
National and Kapodistrian University of Athens, Athens, , Greece
University General Hospital of Ioannina, Ioánnina, , Greece
Theagenion Hospital, Thessaloníki, , Greece
Dél-pesti Centrumkórház - Szent László Kórház telephely, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár, , Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet, Szolnok, , Hungary
Soroka Medical Center, Beer Sheva, , Israel
Rambam Health Care Campus, Haifa, , Israel
Policlinico S. Orsola-Malpighi, Bologna, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliero-Universitaria di Modena, Modena, , Italy
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto, Piacenza, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
AOU Ospedali Riuniti di Ancona, Torrette, , Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma, Verona, , Italy
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Hospital de Braga, Braga, , Portugal
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria, Lisboa, , Portugal
Champalimaud Cancer Center, Lisbon, , Portugal
Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano, Senhora da Hora, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia, , Portugal
Evimed LLC, Chelyabinsk, , Russian Federation
Limited Liability Company- Clinica Druzhkovyh, Kazan, , Russian Federation
Kursk Regional Clinical Oncology Dispensary, Kursk, , Russian Federation
Main Military Clinical Hospital named after N.N. Burdenko, Moscow, , Russian Federation
Volga District Medical Centre, Novgorod, , Russian Federation
Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov, Saint-Petersburg, , Russian Federation
Hospital General Universitario de Elche, Alicante, , Spain
Hospital Universitario de Badajoz, Badajoz, , Spain
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Quironsalud Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona, , Spain
Hospital Vall D Hebron, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell, Barcelona, , Spain
Institut Catala d'Oncologia - L'Hospitalet, Barcelona, , Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves, Granada, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Guy's and St. Thomas' NHS Foundation Trust, London, , United Kingdom
Royal Marsden Foundation Trust, London, , United Kingdom
Royal Marsden Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Contact Details
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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