Spots Global Cancer Trial Database for Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
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Trial Identification
Brief Title: Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Official Title: A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
Study ID: NCT01964430
Study Description
Brief Summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
Detailed Description: ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 043, Scottsdale, Arizona, United States
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
UCSD Moores Cancer Center, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
Local Institution - 044, Sacramento, California, United States
UC Davis Cancer Center, Sacramento, California, United States
Local Institution - 001, San Francisco, California, United States
University of California, San Francisco Cutaneous Oncology and Melanoma Center, San Francisco, California, United States
University of California Los Angeles, Santa Monica, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Local Institution - 059, Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP [Denver-Midtown], Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Local Institution - 022, Boca Raton, Florida, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
Florida Cancer Institute Cancer Spec, Fort Myers, Florida, United States
Local Institution - 031, Fort Myers, Florida, United States
Gainesville Heme Oncology Associates, Gainesville, Florida, United States
Local Institution - 011, Gainesville, Florida, United States
University of Florida, Gainesville, Florida, United States
University of Miami and Sylvester Cancer Center, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Local Institution - 039, Orlando, Florida, United States
H Lee Moffitt Cancer Center, Tampa, Florida, United States
Georgia Cancer Specialist, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Northshore University Healthsystem Research Institute, Evanston, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
University of Louisville, Louisville, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Ochsner Medical Center - Jefferson Highway, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel-Deaconess Medical Center, Boston, Massachusetts, United States
Local Institution - 040, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Local Institution - 045, Boston, Massachusetts, United States
Local Institution - 036, Ann Arbor, Michigan, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Center Wayne State University, Detroit, Michigan, United States
Local Institution - 021, Rochester, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Local Institution - 048, Omaha, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Local Institution - 064, Basking Ridge, New Jersey, United States
MSKCC Basking Ridge, Basking Ridge, New Jersey, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
Local Institution - 025, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, Commack, New York, United States
Memorial Sloan Kettering Cancer Center West Harrison, Harrison, New York, United States
NYU Langone Medical Center, Lake Success, New York, United States
Local Institution - 008, New York, New York, United States
Memorial Sloan-Kettering Cancer Center - NYC, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Local Institution - 032, New York, New York, United States
Local Institution - 013, Rochester, New York, United States
University of Rochester Cancer Center, James P. Wilmot Cancer Center, Rochester, New York, United States
Local Institution - 066, Rockville Center, New York, United States
MSKCC at Mercy Medical Center Mercy RockvilleCenter, Rockville Center, New York, United States
MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow, Sleepy Hollow, New York, United States
State University of New York Upstate Medical Center, Syracuse, New York, United States
Local Institution - 051, Winston-Salem, North Carolina, United States
Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Local Institution - 030, Cincinnati, Ohio, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center, Cincinnati, Ohio, United States
Case Western Reserve Center, Cleveland, Ohio, United States
Local Institution - 047, Cleveland, Ohio, United States
Cleveland Clinic - Taussig Cancer Institute, Cleveland, Ohio, United States
Cleveland Clinic Foundation IRB, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Local Institution - 020, Cleveland, Ohio, United States
Local Institution - 054, Cleveland, Ohio, United States
Local Institution - 005, Columbus, Ohio, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Local Institution - 049, Oklahoma City, Oklahoma, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Local Institution - 019, Portland, Oregon, United States
Oregon Health and Science University OHSU, Portland, Oregon, United States
Local Institution - 016, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Local Institution - 027, Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavillion, Pittsburgh, Pennsylvania, United States
Chattanooga Oncology Hematology Care, Chattanooga, Tennessee, United States
Local Institution - 023, Chattanooga, Tennessee, United States
Local Institution - 004, Nashville, Tennessee, United States
Sarah Cannon Research Inst, Nashville, Tennessee, United States
Local Institution - 002, Nashville, Tennessee, United States
Vanderbilt- Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology, Dallas, Texas, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
Local Institution - 062, Dallas, Texas, United States
Local Institution - 010, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Local Institution - 050, Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Local Institution - 041, Houston, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Local Institution - 038, Charlottesville, Virginia, United States
University of Virginia, Charlottesville, Virginia, United States
Local Institution - 003, Seattle, Washington, United States
Seattle Cancer Care Alliance - Seattle, Seattle, Washington, United States
Virginia Mason Cancer Center, Seattle, Washington, United States
Local Institution - 014, Madison, Wisconsin, United States
University of Wisconsin - Madison Cancer Center, Madison, Wisconsin, United States
Canberra Hospital, Garran, Australian Capital Territory, Australia
Local Institution - 505, Garran, Australian Capital Territory, Australia
Local Institution - 501, Darlinghurst, New South Wales, Australia
Local Institution - 507, St Leonards, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Local Institution - 504, Herston, Queensland, Australia
ICON Cancer Center, Milton, Queensland, Australia
Local Institution - 502, Milton, Queensland, Australia
Local Institution - 506, Bentleigh East, Victoria, Australia
Local Institution - 508, Subiaco, Western Australia, Australia
St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
Monash Medical Centre Moorabbin Campus, Bentleigh East, , Australia
Saint Vincent's Hospital, Darlinghurst, , Australia
Austin Hospital, Heidelberg, , Australia
Local Institution - 509, Heidelberg, , Australia
Royal Brisbane and Women's Hospital, Herston, , Australia
Cabrini Hospital, Malvern, , Australia
Local Institution - 503, Malvern, , Australia
Local Institution - 500, Randwick, , Australia
Prince of Wales Hospital, Randwick, , Australia
The Queen Elizabeth Hospital, Woodville South, , Australia
Local Institution - 205, Graz, , Austria
Medical University of Graz, Graz, , Austria
Local Institution - 203, Innsbruck, , Austria
Medical University Innsbruck, Innsbruck, , Austria
Hospital of Elisabethinen Linz, Linz, , Austria
Local Institution - 206, Linz, , Austria
Local Institution - 204, Salzburg, , Austria
Salzburger Landkliniken St. Johanns-Spital, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Local Institution - 0207, Wels, , Austria
Hospital Wiener Neustadt, Wiener Neustadt, , Austria
Local Institution - 202, Wiener Neustadt, , Austria
Local Institution - 200, Wien, , Austria
Medizinische Universitat Wien, Wien, , Austria
Kaiser-Franz-Josef Spital, Wien, , Austria
Local Institution - 201, Wien, , Austria
Hopital Erasme, Brussels, , Belgium
Local Institution - 211, Brussels, , Belgium
UZ Antwerpen, Edegem, , Belgium
Local Institution - 213, Gent, , Belgium
UZ Gent, Gent, , Belgium
Local Institution - 210, Leuven, , Belgium
UZ Leuven, Leuven, , Belgium
Local Institution - 102, Calgary, Alberta, Canada
Tom Baker Cancer Center, Calgary, Alberta, Canada
Local Institution - 101, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Local Institution - 100, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier de L'Universite de Montreal St-Luc, Montreal, Quebec, Canada
Local Institution - 104, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Local Institution - 103, Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Local Institution - 220, Hradec Kralove, , Czechia
Krajska nemocnice Liberec, a.s., Liberec, , Czechia
Krajska nemocnice T. Bati a.s., Zlin, , Czechia
Local Institution - 221, Zlin, , Czechia
Hæmatologisk afd. B Aalborg Sygehus Syd, Aalborg, , Denmark
Local Institution - 231, Aalborg, , Denmark
Herlev Hospital, Herlev, , Denmark
Local Institution - 232, Herlev, , Denmark
Local Institution - 230, Odense C, , Denmark
Onk.Dep., Odense Universitets hospital, Odense C, , Denmark
Local Institution - 240, Tampere, Oulun Lääni, Finland
Helsingin yliopistollinen keskussairaala, Helsinki, , Finland
Local Institution - 241, Helsinki, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
Local Institution - 242, Turku, , Finland
Turku University Hospital, Turku, , Finland
Center Hospitalier Universitaire d' Angers, Angers cedex 09, , France
Local Institution - 253, Angers cedex 09, , France
Hopital Henri Mondor, Creteil, , France
CHRU de Lille France, Lille, , France
Local Institution - 257, Lille, , France
Hopital Edouard Herriot - Hepato-gastroenterologie, Lyon Cedex 3, , France
Local Institution - 258, Lyon Cedex 3, , France
Hopital prive Jean Mermoz, Lyon, , France
Local Institution - 252, Lyon, , France
Hopital Europeen Georges Pompidou, Paris, , France
Local Institution - 250, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Pitie Salpetriere, Paris, , France
Local Institution - 259, Paris, , France
CHU La Miletrie, Poitiers Cedex, , France
Local Institution - 251, Poitiers Cedex, , France
Local Institution - 256, Toulose, , France
Pole Des Specialites Medicales, Hopital Purpan, Toulose, , France
Klinikum Weiden, Bayern, , Germany
Local Institution - 280, Bayern, , Germany
Charite - Universitätsmedizin Berlin, Berlin, , Germany
Local Institution - 272, Berlin, , Germany
Local Institution - 278, Dresden, , Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Local Institution - 277, Frankfurt, , Germany
Universitatsklinkum Frankfurt, Frankfurt, , Germany
Local Institution - 284, Frechen, , Germany
Praxis Internistischer Onkologie und Hamatologie Frechen, Frechen, , Germany
Local Institution - 275, Friedrichshafen, , Germany
Praxis für Innere Medizin, Dr.Oettle Helmut, Friedrichshafen, , Germany
Ernst-Moritz-Arndt-Universität Greifswald, Greifswald, , Germany
Local Institution - 279, Greifswald, , Germany
Local Institution - 273, Hamburg, , Germany
Universitaetsklinik Hamburg - Eppendorf, Hamburg, , Germany
Local Institution - 281, Köln, , Germany
Praxis Internistischer Onkologie und Hamatologie Koln, Köln, , Germany
Local Institution - 274, Magdeburg, , Germany
Universitatsklinik Magdeburg, Magdeburg, , Germany
Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie, Mainz, , Germany
Local Institution - 283, Mainz, , Germany
Klinikum der Universitat Munchen-Grosshadern, München, , Germany
Local Institution - 282, München, , Germany
Klinikum Neuperlach, München, , Germany
Local Institution - 276, München, , Germany
Local Institution - 0271, Tübingen, , Germany
University of Tubingen, Tübingen, , Germany
Local Institution - 270, Würzburg, , Germany
Universitatsklinikum Würzburg, Würzburg, , Germany
Local Institution - 601, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Tuen Mun Hospital, Hong Kong, , Hong Kong
Local Institution - 602, Sha Tin, , Hong Kong
Prince of Wales Hospital the Chinese University of Hong Kong, Sha Tin, , Hong Kong
Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet, Budapest, , Hungary
Local Institution - 293, Budapest, , Hungary
Local Institution - 291, Budapest, , Hungary
Uzsoki Utcai Korhaz, Budapest, , Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen, , Hungary
Local Institution - 290, Debrecen, , Hungary
Local Institution - 292, Gyor, , Hungary
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat, Gyor, , Hungary
Local Institution - 295, Szeged, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy, Szeged, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Local Institution - 311, Cork, , Ireland
Cork University Hospital, Cork, , Ireland
Local Institution - 310, Dublin 4, , Ireland
St Vincent's University Hospital, Dublin 4, , Ireland
Local Institution - 329, Terni, Umbria, Italy
Local Institution - 325, Ancona, , Italy
Ospedali Riuniti Umberto I GM Lancisi, Ancona, , Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy
Local Institution - 330, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Local Institution - 328, Firenze, , Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola, , Italy
Local Institution - 331, Meldola, , Italy
Local Institution - 321, Milano, , Italy
Ospedale San Raffaele S.r.l., Milano, , Italy
Azienda Ospedaliera Niguarda Ca Granda, Milano, , Italy
Local Institution - 322, Milano, , Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, , Italy
Local Institution - 324, Pisa, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Local Institution - 333, Reggio Emilia, , Italy
Local Institution - 323, Roma, , Italy
Local Institution - 327, Roma, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Local Institution - 326, Rozzano (MI), , Italy
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
Local Institution - 332, San Giovanni Rotondo, , Italy
Azienda Ospedaliera S Maria di Terni, Terni, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona, Verona, , Italy
Local Institution - 320, Verona, , Italy
Local Institution - 641, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Local Institution - 642, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Local Institution - 640, Seoul, , Korea, Republic of
Academisch Medisch Centrum Amsterdam, Amsterdam, , Netherlands
Local Institution - 400, Amsterdam, , Netherlands
Catharina Hospital, Eindhoven, , Netherlands
Local Institution - 403, Eindhoven, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Local Institution - 402, Zwolle, , Netherlands
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos, Lisboa, , Portugal
Local Institution - 340, Lisboa, , Portugal
Hospital Da Luz, Lisboa, , Portugal
Local Institution - 341, Lisboa, , Portugal
Hospital de Sao Joao, Porto, , Portugal
Local Institution - 342, Porto, , Portugal
Local Institution - 610, Singapore, , Singapore
National University Hospital, Singapore, , Singapore
Local Institution - 611, Singapore, , Singapore
National Cancer Center, Singapore, , Singapore
Local Institution - 371, Santander, Cantabria, Spain
Local Institution - 360, Barcelona, , Spain
Clinic Barcelona Hospital Universitari, Barcelona, , Spain
Local Institution - 363, Barcelona, , Spain
Instituto Catalan de Oncologia-Hospital Duran, Barcelona, , Spain
Local Institution - 370, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Gregorio Maranon, Madrid, , Spain
Local Institution - 367, Madrid, , Spain
Local Institution - 362, Madrid, , Spain
Ramon y Cajal Univeresity Hospital, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Local Institution - 372, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Local Institution - 365, Madrid, , Spain
Centro Integral, Madrid, , Spain
Local Institution - 361, Madrid, , Spain
Hospital General Carlos Haya, Malaga, , Spain
Local Institution - 369, Malaga, , Spain
Complejo Hospitalario de Navarra, Pamplona/ Navarra, , Spain
Local Institution - 368, Pamplona/ Navarra, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Clinico Universitario De Santiago De Compostela, Santiago De Compostela, , Spain
Local Institution - 366, Santiago De Compostela, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Local Institution - 364, Sevilla, , Spain
Local Institution - 620, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Local Institution - 625, Tainan, Taiana, , Taiwan
National Cheng Kung University Hospital, Tainan, Taiana, , Taiwan
Local Institution - 623, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Local Institution - 622, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch, Taoyuan, , Taiwan
Local Institution - 624, Taoyuan, , Taiwan
Local Institution - 621, Tapei, , Taiwan
National Taiwan University Hospital, Tapei, , Taiwan
Addenbrookes Hospital, Cambridge, , United Kingdom
Local Institution - 382, Cambridge, , United Kingdom
Glasgow Royal Infirmary, Glasgow, , United Kingdom
Local Institution - 380, Glasgow, , United Kingdom
Weston Park Hospital, Sheffield South Yorkshire, , United Kingdom
Local Institution - 381, Sheffield, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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