A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

674

Participants

Timeline

Start Date

August 1, 2007

Primary Completion Date

April 7, 2016

Study Completion Date

September 7, 2017

Conditions
Kidney Neoplasms
Interventions
DRUG

Sunitinib malate

sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.

OTHER

Placebo

Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent

Trial Locations (115)

0

Instituto Nacional de Cancerologia - ESE, Bogota

7

Mater Misericordiae Hospital, Dublin

9

Beaumont Hospital, Dublin

24

AMNCH Hospital, Dublin

112

Taipei Veterans General Hospital, Taipei

3010

Onkologisches Institut, Inselspital Bern, Bern

3165

Monash Medical Centre - Moorabin Campus, East Bentleigh

8000

Aarhus Universitetshospital, Aarhus C

10065

Memorial Sloan Kettering Cancer Center, New York

10117

Charite Universitaetsmedizin Berlin, Campus Charite Mitte, Berlin

10408

National Cancer Center, Goyang-si

11528

"Alexandra general hospital of Athens, department of Clinical Therapeutics, Oncology Unit", Athens

12200

Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin

13273

Institut Paoli-Calmettes, Marseille

13620

Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si

15006

Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera, A Coruña

16132

IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova

19111

Fox Chase Cancer Center, Philadelphia

20133

Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie, Hamburg

23538

Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck, Lübeck

26100

Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona, Cremona

27710

Duke University Medical Center, Durham

28041

Hospital 12 de Octubre, Madrid

29572

Carolina Urologic Research Center, Myrtle Beach

30322

Emory University Hospital, Atlanta

The Emory Clinic, Inc, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31059

Institut Claudius Regaud - Centre de Lutte Contre le Cancer, Toulouse

33000

Hopital Saint-Andre, Bordeaux

34298

CRLC Val d'Aurelle, Montpellier

35042

Centre Eugene Marquis, Rennes

37044

CHRU de Tours - Hopital Bretonneau, Tours

39670

Torre Medica Cristobal Colon, Acapulco de Juárez

40138

Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi, Bologna

40705

Taichung Veterans General Hospital, Taichung

44805

Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau, Saint-Herblain

46009

Instituto Valenciano de Oncologia, Valencia

48149

Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie, Münster

49100

Institute of Oncology, Davidoff Center, Petah Tikva

52074

RWTH Aachen, Urologische Klinik, Aachen

53105

Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie, Bonn

54007

Theageneio Anticancer Hospital, Thessaloniki

59020

Centre Oscar Lambret, Lille

60590

Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II, Frankfurt

65653

Masarykuv onkologicky ustav, Brno

66013

P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica, Chieti Scalo

66421

Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie, Homburg/Saar

67091

Hopital Civil, Strasbourg

70006

Hematology and Oncology Specialists, LLC, Metairie

70072

Hematology and Oncology Specialists, LLC, Marrero

70300

Assaf Harofeh Medical Center, Ẕerifin

72076

Eberhardt-Karls-Universität Tübingen, Klinik für Urologie, Tübingen

75185

Urologkliniken Akademiska Sjukhuset, Uppsala

75908

Hopital Europeen Georges Pompidou, Paris

80131

Divisione di Oncologia, AORN Antonio Cardarelli, Napoli

81377

Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik, München

84107

Intermountain Medical Center, Murray

89075

Universitaetsklinikum Ulm, Urologische Universitaetsklinik, Ulm

90095

Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services, Los Angeles

UCLA Clark Urology Center, Los Angeles

90419

Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie, Nuremberg

93586

Sarawak General Hospital, Kuching

94805

Institut Gustave Roussy / Service d'Immunotherapie, Villejuif

100021

Cancer Institute & Hospital, CAMS, Beijing

100034

Department of Urology,Peking University First Hospital, Beijing

100853

Chinese PLA General Hospital/Urology Department, Beijing

200032

Fudan University Cancer Hospital, Department of Urology, Shanghai

200040

Huashan Hospital Fudan University, Shanghai

200127

Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine, Shanghai

200433

Department of Urology, Shanghai Changhai Hospital, Shanghai

215006

The first affiliated hospital of Soochow university/Department of Urology, Suzhou

300060

Tianjin Oncology Hospital, urology department, Tianjin

300211

The Second Hospital of Tianjin Medical University, Tianjin

310009

Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou

400038

Urology Department, South-Western Hospital, 3rd Military Medical University., Chongqing

510060

Urology Department, Sun Yet-Sen University Cancer Center, Guangzhou

27599-7600

The University of North Carolina at Chapel Hill, Chapel Hill

656 53

Masarykuv onkologicky ustav, Brno

150 06

Fakultni nemocnice v Motole, Klinika zobrazovacich metod, Prague

Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni, Prague

Fakultni nemocnice v Motole, Ustav nuklearni mediciny, Prague

401 13

Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z., Ústí nad Labem

01307

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden, Dresden

07740

Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie, Jena

Unknown

University Hospital Galway, Galway

31-108

"Vesalius Sp. z o.o.", Krakow

90-549

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A, Lodz

Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow, Lodz

60-569

Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego, Poznan

02-781

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Warsaw

04-141

Klinika Onkologii, Wojskowy Instytut Medyczny, Warsaw

50-556

Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny, Wroclaw

833 05

Univerzitna nemocnica Bratislava, Bratislava

833 10

Narodny Onkologicky ustav, Bratislava

036 59

Univerzitna nemocnica Martin, Martin

012 07

Fakultna nemocnica s poliklinikou, Žilina

06351

Samsung Medical Center, Seoul

05505

Asan Medical Center, Seoul

02841

Korea University Anam Hospital, Seoul

08908

Institut Catala D'Oncologia (I.C.O), L'Hospitalet de Llobregat

08035

Hospital Universitario Vall D'Hebron, Barcelona

08036

Hospital Clinico de Barcelona, Barcelona

413 45

Verksamheten urologi, SU/Sahlgrenska, Gothenburg

221 85

Onkologiska kliniken, Universitetssjukhuset, Lund

901 85

Norrlands universitetssjukhus, Urologiska kliniken, Umeå

751 85

Akademiska sjukhuset, Uppsala

721 89

Centrallasarettet, Onkologkliniken, Västerås

CH-9007

Kantonsspital St. Gallen, Sankt Gallen

G12 0YH

The Beatson West of Scotland Cancer Centre, Glasgow

G52 3NQ

Ross Hall Hospital, Glasgow

GU2 7WG

Post Graduate Medical School, University of Surrey, Guildford

SE1 9RT

Guy's Hospital, London

W2 1NY

St. Mary's Hospital, Imperial College, Health care NHS Trust, London

M20 4BX

Medical Oncology, Patterson institute for Cancer Research, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00375674 - A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer | Biotech Hunter | Biotech Hunter