Spots Global Cancer Trial Database for Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer
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Trial Identification
Brief Title: Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer
Official Title: A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer
Study ID: NCT04163900
Conditions
Study Description
Brief Summary: NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: * The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care * The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates , PC - HOPE, Tucson, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
Rocky Mountain Cancer Centers, LLP- Aurora, Aurora, Colorado, United States
Baptist Health Medical Group Oncology, LLC, Miami, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
IACT Health, Columbus, Georgia, United States
Affiliated Oncologists LLC, Chicago Ridge, Illinois, United States
University of Kansas Medical Center Research Institute, Inc., Westwood, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Henry Ford Medical Group, Detroit, Michigan, United States
Minnesota Oncology Hemtology, Minneapolis, Minnesota, United States
Regents of the University of Minnesota, Minneapolis, Minnesota, United States
University of Rochester Medical Center - Strong Memorial Hospital, Rochester, New York, United States
The Research Foundation for The State University of New York, Stony Brook, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
The Ohio State University James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania, United States
Prisma Health Upstate, Greenville, South Carolina, United States
Texas Oncology, P.A. - Austin, Austin, Texas, United States
Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Northwest Cancer Specialists, P.C.-Vancouver, Vancouver, Washington, United States
Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States
The Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St George Hospital, Kogarah, New South Wales, Australia
Newcastle Private Hospital, Newcastle, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Townsville Cancer Centre, Townsville, Queensland, Australia
Warringal Medical Centre, Heidelberg, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CHUM Centre de Recherche, Montréal, Quebec, Canada
SMBD Jewish General Hospital, Montréal, Quebec, Canada
Fakultní nemocnice Brno, Brno, , Czechia
Fakultní nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Thomayerova nemocnice, Prague, , Czechia
Nemocnice Na Homolce, Prague, , Czechia
Centre Georges François Leclerc, Dijon, , France
CHU de Grenoble - Hôpital Nord, Grenoble, , France
Institut Hospitalier Franco-Britannique, Levallois-Perret, , France
Hôpital Cochin, Paris, , France
ICO - Site René Gauducheau, Saint Herblain, , France
Universitaetsklinikum Heidelberg, Heidelberg, Baden Wuerttemberg, Germany
Vivantes Klinikum Neukoelln, Berlin, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Medizinische Hochschule Hannover, Hanover, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Miskolc, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Ospedale Policlinico San Martino, Genova, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Centro Ricerche Cliniche di Verona S.r.l, Verona, , Italy
CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Dong-A University Hospital, Pusan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin, Moscow, , Russian Federation
"VitaMed" LLC, Moscow, , Russian Federation
State Budget Institution of Healthcare "Leningrad Regional Clinical Oncology Dispensary", Saint Petersburg, , Russian Federation
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, , Russian Federation
SPb SBIH "City Clinical Oncological Dispensary", Saint Petersburg, , Russian Federation
Medicinskiy gorod, Tyumen, , Russian Federation
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet De Llobregat, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Acibadem Adana Hospital, Adana, , Turkey
Baskent University Adana Application and Research Center, Adana, , Turkey
Akdeniz University Medical Faculty, Antalya, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital, Malatya, , Turkey
Inonu University Medical Facility, Malatya, , Turkey
CI Chernivtsi RC Oncological Dispensary, Chernivtsi, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU, Kharkiv, , Ukraine
CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection, Kharkiv, , Ukraine
Kyiv City Clinical Oncological Center, Kyiv, , Ukraine
SI "Shalimov's National Institute of Surgery and Transplantation" of NAMSU, Kyiv, , Ukraine
Treatment-Prevention Institution Volyn Regional Oncological Dispensary, Luts'k, , Ukraine
Communal Institution Odesa Regional Clinical Hospital, Odesa, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
Guy's Hospital, London, Greater London, United Kingdom
The Christie, Manchester, Greater Manchester, United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Torbay Hospital, Torquay, , United Kingdom
The Clatterbridge Cancer Centre, Wirral, , United Kingdom
Contact Details
Name: Jennifer Knox, MD
Affiliation: Professor of Medicine, University of Toronto
Role: PRINCIPAL_INVESTIGATOR
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