Last updated on February 2019

Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)


Brief description of study

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).

Clinical Study Identifier: NCT03040999

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St. Joseph Heritage Healthcare ( Site 0254)
Santa Rosa, CA United States
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Smilow Cancer Hospital at Yale New Haven ( Site 0256)
New Haven, CT United States
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Rush University Medical Center ( Site 0260)
Chicago, IL United States
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Indiana University ( Site 0264)
Indianapolis, IN United States
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University of Michigan Hospital and Health Systems ( Site 0267)
Ann Arbor, MI United States
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Barbara Ann Karmanos Cancer Institute ( Site 0272)
Detroit, MI United States
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Comprehensive Cancer Centers of Nevada ( Site 8004)
Las Vegas, NV United States
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University of Rochester - James P. Wilmot Cancer Center ( Site 0255)
Rochester, NY United States
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Oncology Hematology Care, Inc. ( Site 8003)
Cincinnati, OH United States
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St. Luke's Cancer Center - Anderson ( Site 0251)
Easton, PA United States
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Texas Oncology-Austin Central ( Site 8002)
Austin, TX United States
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Texas Oncology PA ( Site 8001)
Longview, TX United States
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University of Virginia Health System ( Site 0261)
Charlottesville, VA United States
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Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)
Seattle, WA United States
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Royal Adelaide Hospital ( Site 0303)
Adelaide, Australia
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Peter MacCallum Cancer Centre ( Site 0300)
Melbourne, Australia
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Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)
Graz, Austria
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Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)
Linz, Austria
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Landeskrankenhaus Salzburg ( Site 0600)
Salzburg, Austria
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Allgemeines Krankenhaus der Stadt Wien ( Site 0602)
Vienna/Wien, Austria
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UZ Gent ( Site 0650)
Gent, Belgium
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UZ Leuven Campus Gasthuisberg ( Site 0652)
Leuven, Belgium
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C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)
Liege, Belgium
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Clinique et Maternite Sainte-Elisabeth ( Site 0653)
Namur, Belgium
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Tom Baker Cancer Centre ( Site 0063)
Calgary, AB Canada
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Juravinski Cancer Centre ( Site 0062)
Hamilton, ON Canada
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London Health Sciences Centre ( Site 0055)
London, ON Canada
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The Ottawa Hospital - Cancer Care ( Site 0052)
Ottawa, ON Canada
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Princess Margaret Cancer Centre ( Site 0051)
Toronto, ON Canada
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CIUSSS de l'Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)
Sherbrooke, QC Canada
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Centro de Investigacion Clinica del Country ( Site 0155)
Bogota, Colombia
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Fundacion Valle del Lili ( Site 0150)
Cali, Colombia
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Hospital Pablo Tobon Uribe ( Site 0151)
Medellin, Colombia
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FN Brno. ( Site 0703)
Brno, Czechia
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Fakultni Nemocnice Hradec Kralove ( Site 0705)
Hradec Kralove, Czechia
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Fakultni nemocnice Olomouc ( Site 0701)
Olomouc, Czechia
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Fakultni nemocnice Ostrava ( Site 0702)
Ostrava, Czechia
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2. LF UK a FN Motol ( Site 0704)
Praha 5, Czechia
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Nemocnice Na Bulovce ( Site 0700)
Praha 8, Czechia
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Clinique Francois Chenieux ( Site 0757)
Limoges, France
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Institut Claudius Regaud ( Site 0754)
Toulouse Cedex 09, France
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Institut De Cancerologie De Lorraine ( Site 0758)
Vandoeuvre les Nancy, France
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Institut Gustave Roussy ( Site 0759)
Villejuif, France
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Universit tsklinikum Erlangen ( Site 0801)
Erlangen, Germany
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SRH Waldklinikum Gera GmbH ( Site 0802)
Gera, Germany
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Medizinische Hochschule Hannover ( Site 0807)
Hannover, Germany
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Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)
Luebeck, Germany
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Universitaetsklinik Ulm ( Site 0804)
Ulm, Germany
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Rambam MC ( Site 0903)
Haifa, Israel
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Hadassah Ein Karem Jerusalem ( Site 0902)
Jerusalem, Israel
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Rabin Medical Center ( Site 0904)
Petah Tikva, Israel
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Sheba MC ( Site 0901)
Ramat Gan, Israel
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Tel Aviv Sourasky Medical Center ( Site 0900)
Tel Aviv, Israel
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Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)
Modena, Italy
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Azienda Ospedaliero Universitaria Careggi ( Site 0955)
Firenze, Italy
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National Cancer Center Hospital East ( Site 0350)
Kashiwa, Japan
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Hokkaido University Hospital ( Site 0351)
Sapporo, Japan
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Hyogo Cancer Center ( Site 0354)
Akashi, Japan
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Miyagi Cancer Center ( Site 0353)
Natori, Japan
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Hiroshima University Hospital ( Site 0352)
Hiroshima, Japan
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Medical Hospital, Tokyo Medical And Dental University ( Site 0356)
Tokyo, Japan
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Chungbuk National University Hospital ( Site 0454)
Cheongju si, Korea, Republic of
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Seoul National University Bundang Hospital ( Site 0453)
Seongnam-si, Korea, Republic of
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Chungnam National University Hospital ( Site 0455)
Daejeon, Korea, Republic of
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Samsung Medical Center ( Site 0450)
Seoul, Korea, Republic of
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Severance Hospital Yonsei University Health System ( Site 0452)
Seoul, Korea, Republic of
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Noordwest Ziekenhuisgroep NWZ ( Site 1350)
Alkmaar, Netherlands
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VU Medisch Centrum ( Site 1352)
Amsterdam, Netherlands
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UMCG ( Site 1351)
Groningen, Netherlands
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Erasmus University Medical Center ( Site 1354)
Rotterdam, Netherlands
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Capital & Coast District Health Board - Wellington Hospital ( Site 0400)
Wellington, New Zealand
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Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)
Bielsko-Biala, Poland
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Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)
Gliwice, Poland
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Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)
Krakow, Poland
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Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)
Warszawa, Poland
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H.U. Vall de Hebron ( Site 1052)
Barcelona, Spain
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Hospital Duran i Reynals ( Site 1053)
Hospitalet de Llobregat, Spain
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Hospital Clinico San Carlos ( Site 1051)
Madrid, Spain
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Hospital Doce de Octubre ( Site 1054)
Madrid, Spain
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Hospital Universitario Ramon y Cajal ( Site 1055)
Madrid, Spain
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Hospital Universitario Virgen de la Victoria ( Site 1056)
Malaga, Spain
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Hospital Gral Universitario de Valencia ( Site 1050)
Valencia, Spain
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Chang Gung Medical Foundation - Kaohsiung ( Site 0501)
Kaohsiung, Taiwan
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National Cheng Kung University Hospital ( Site 0503)
Tainan, Taiwan
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MacKay Memorial Hospital ( Site 0505)
Taipei, Taiwan
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National Taiwan University Hospital ( Site 0500)
Taipei, Taiwan
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Taipei Veterans General Hospital ( Site 0504)
Taipei, Taiwan
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Linkou Chang Gung Memorial Hospital ( Site 0502)
Taoyuan, Taiwan
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Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)
Ankara, Turkey
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YBU Ataturk Egitim ve Arastirma Hastanesi ( Site 1108)
Ankara, Turkey
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Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)
Istanbul, Turkey
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Medical Park Izmir Hastanesi ( Site 1109)
Izmir, Turkey
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Kocaeli Universitesi Tip Fakultesi ( Site 1106)
Kocaeli, Turkey
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Inonu Universitesi Tip Fakultesi ( Site 1101)
Malatya, Turkey
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Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)
Preston, United Kingdom
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UCLA Medical Center ( Site 0273)
Los Angeles, CA United States
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University of Massachusetts Memorial Medical Center ( Site 0285)
Worcester, MA United States
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St. Vincent Healthcare Frontier Cancer Center ( Site 0286)
Billings, MT United States
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Liverpool Hospital ( Site 0301)
Liverpool, Australia
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Blacktown Hospital Western Sydney Local Health District ( Site 0304)
Blacktown, Australia
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Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)
Salvador, Brazil
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Centro Regional Integrado de Oncologia ( Site 0002)
Fortaleza, Brazil
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Hospital Nossa Senhora da Conceicao ( Site 0001)
Porto Alegre, Brazil
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Hospital de Clinicas de Porto Alegre ( Site 0011)
Porto Alegre, Brazil
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Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)
Barretos, Brazil
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Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)
Ribeirao Preto, Brazil
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Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)
Sao Paulo, Brazil
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Cross Cancer Institute ( Site 0064)
Edmonton, AB Canada
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Universitares Cancer Center Hamburg - UCCH ( Site 0811)
Hamburg, Germany
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Klinikum der Universitaet Munchen ( Site 0810)
Munchen, Germany
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Azienda Ospedaliera San Paolo ( Site 0952)
Milano, Italy
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The Cancer Institute Hospital of JFCR ( Site 0357)
Tokyo, Japan
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Dolnoslaskie Centrum Onkologii. ( Site 1001)
Wroclaw, Poland
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Zachodniopomorskie Centrum Onkologii ( Site 1013)
Szczecin, Poland
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Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)
Adana, Turkey
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Ipswich Hospital ( Site 1207)
Ipswich, United Kingdom
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Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)
London, United Kingdom
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The Royal Marsden Foundation Trust ( Site 1200)
London, United Kingdom
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Royal Marsden NHS Foundation Trust ( Site 1201)
Sutton, United Kingdom
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University of California San Francisco ( Site 0274)
San Francisco, CA United States
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Mary Bird Perkins Cancer Center ( Site 0281)
Baton Rouge, LA United States
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Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)
Spokane, WA United States
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Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)
Le Mans, France
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Istituto Europeo di Oncologia ( Site 0953)
Milano, Italy
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Mazowiecki Szpital Onkologiczny ( Site 1015)
Wieliszew, Poland
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University Hospital Southampton NHS Foundation Trust ( Site 1203)
Southampton, United Kingdom
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Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)
Napoli, Italy
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Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)
Norwich, United Kingdom
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St Bartholomew s Hospital ( Site 1205)
London, United Kingdom
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Osaka International Cancer Institute ( Site 0355)
Osaka, Japan
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Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)
Gdynia, Poland
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Chiba Cancer Center ( Site 0358)
Chiba, Japan
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Istituto Nazionale Tumori ( Site 0950)
Milano, Italy
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University Hospital of North Staffordshire ( Site 1202)
Stoke-On-Trent, United Kingdom
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Royal Brisbane and Women s Hospital ( Site 0302)
Herston, Australia
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Kagawa University Hospital ( Site 0359)
Kita-gun, Japan
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Centro Medico Imbanaco de Cali S.A ( Site 0156)
Cali, Colombia
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Taichung Veterans General Hospital ( Site 0506)
Taichung, Taiwan
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Princess Alexandra Hospital ( Site 0305)
Brisbane, Australia
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Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)
Brussels, Belgium
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Istituto Oncologico Veneto ( Site 0957)
Padova, Italy
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Willamette Valley Cancer Institute and Research Center ( Site 8000)
Eugene, OR United States
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UMC St. Radboud ( Site 1356)
Nijmegen, Netherlands
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St. Francis Hospital Cancer Center ( Site 1461)
Greenville, SC United States
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Medipol Universite Hastanesi ( Site 1104)
Istanbul, Turkey
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Texas Oncology-Arlington North ( Site 8005)
Arlington, TX United States
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McGill University Health Centre - Royal Victoria Hospital ( Site 0061)
Montreal, QC Canada
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Fondazione IRCCS - Policlinico San Matteo ( Site 0960)
Pavia, Italy
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Recruitment Status: Open


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