Kidney Cancer Clinical Trial

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

Summary

To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

High risk renal cancer per modified UISS criteria
Eastern Cooperative Oncology Group (ECOG) 0-2
predominant clear cell histology
No prior anti-cancer treatment
Kidney tumor has been removed
No evidence of macroscopic disease following surgery

Exclusion Criteria:

Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
known HIV or Hepatitis
any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

674

Study ID:

NCT00375674

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 109 Locations for this study

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Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
Los Angeles California, 90095, United States
UCLA Clark Urology Center
Los Angeles California, 90095, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
The Emory Clinic, Inc
Atlanta Georgia, 30322, United States
Hematology and Oncology Specialists, LLC
Marrero Louisiana, 70072, United States
Hematology and Oncology Specialists, LLC
Metairie Louisiana, 70006, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Intermountain Medical Center
Murray Utah, 84107, United States
Monash Medical Centre - Moorabin Campus
East Bentleigh Victoria, 3165, Australia
Urology Department, Sun Yet-Sen University Cancer Center
Guangzhou Guangdong, 51006, China
The first affiliated hospital of Soochow university/Department of Urology
Suzhou Jiangsu, 21500, China
Fudan University Cancer Hospital, Department of Urology
Shanghai Shanghai, 20003, China
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai Shanghai, 20012, China
Department of Urology, Shanghai Changhai Hospital
Shanghai Shanghai, 20043, China
Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou Zhejiang, 31000, China
Cancer Institute & Hospital, CAMS
Beijing , 10002, China
Department of Urology,Peking University First Hospital
Beijing , 10003, China
Chinese PLA General Hospital/Urology Department
Beijing , 10085, China
Urology Department, South-Western Hospital, 3rd Military Medical University.
Chongqing , 40003, China
Huashan Hospital Fudan University
Shanghai , 20004, China
Tianjin Oncology Hospital, urology department
Tianjin , 30006, China
The Second Hospital of Tianjin Medical University
Tianjin , 30021, China
Instituto Nacional de Cancerologia - ESE
Bogota Cundinamarca, 0, Colombia
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Masarykuv onkologicky ustav
Brno , 65653, Czechia
Fakultni nemocnice v Motole, Klinika zobrazovacich metod
Praha 5 , 150 0, Czechia
Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
Praha 5 , 150 0, Czechia
Fakultni nemocnice v Motole, Ustav nuklearni mediciny
Praha 5 , 150 0, Czechia
Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
Usti nad Labem , 401 1, Czechia
Aarhus Universitetshospital
Aarhus C , 8000, Denmark
Hopital Saint-Andre
Bordeaux , 33000, France
Centre Oscar Lambret
Lille , 59020, France
Institut Paoli-Calmettes
Marseille Cedex 09 , 13273, France
CRLC Val d'Aurelle
MONTPELLIER Cedex 5 , 34298, France
Hopital Europeen Georges Pompidou
Paris Cedex 15 , 75908, France
Centre Eugene Marquis
Rennes , 35042, France
Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau
Saint Herblain , 44805, France
Hopital Civil
Strasbourg , 67091, France
Institut Claudius Regaud - Centre de Lutte Contre le Cancer
Toulouse Cedex 9 , 31059, France
CHRU de Tours - Hopital Bretonneau
Tours Cedex 1 , 37044, France
Institut Gustave Roussy / Service d'Immunotherapie
Villejuif Cedex , 94805, France
RWTH Aachen, Urologische Klinik
Aachen , 52074, Germany
Charite Universitaetsmedizin Berlin, Campus Charite Mitte
Berlin , 10117, Germany
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin , 12200, Germany
Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
Bonn , 53105, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden , 01307, Germany
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt , 60590, Germany
Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
Hamburg , 20246, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
Homburg/Saar , 66421, Germany
Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
Jena , 07740, Germany
Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
Luebeck , 23538, Germany
Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
Muenchen , 81377, Germany
Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
Muenster , 48149, Germany
Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
Nuernberg , 90419, Germany
Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
Tuebingen , 72076, Germany
Universitaetsklinikum Ulm, Urologische Universitaetsklinik
Ulm , 89075, Germany
"Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
Athens , 11528, Greece
Theageneio Anticancer Hospital
Thessaloniki , 54007, Greece
AMNCH Hospital
Dublin , 24, Ireland
Mater Misericordiae Hospital
Dublin , 7, Ireland
Beaumont Hospital
Dublin , 9, Ireland
University Hospital Galway
Galway , , Ireland
Institute of Oncology, Davidoff Center
Petach-Tikva , 49100, Israel
Assaf Harofeh Medical Center
Zerifin , 70300, Israel
Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
Chieti Scalo , 66013, Italy
Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
Cremona , 26100, Italy
IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
Genova , 16132, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
Milano , 20133, Italy
Divisione di Oncologia, AORN Antonio Cardarelli
Napoli , 80131, Italy
Department of Internal Medicine, Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
National Cancer Center
Goyang-si Gyeonggido, Korea, Republic OF, 10408, Korea, Republic of
Asan Medical Center
Seoul Seoul Korea, Republic OF, 05505, Korea, Republic of
Korea University Anam Hospital
Seoul Seoul Teugbyeolsi, 02841, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Sarawak General Hospital
Kuching Sarawak, 93586, Malaysia
Torre Medica Cristobal Colon
Acapulco Gro., 39670, Mexico
"Vesalius" Sp. z o.o.
Krakow , 31-10, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
Lodz , 90-54, Poland
Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
Lodz , 90-54, Poland
Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan , 60-56, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Klinika Onkologii, Wojskowy Instytut Medyczny
Warszawa , 04-14, Poland
Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
Wroclaw , 50-55, Poland
Univerzitna nemocnica Bratislava
Bratislava , 833 0, Slovakia
Narodny Onkologicky ustav
Bratislava , 833 1, Slovakia
Univerzitna nemocnica Martin
Martin , 036 5, Slovakia
Fakultna nemocnica s poliklinikou
Zilina , 012 0, Slovakia
Institut Catala D'Oncologia (I.C.O)
L'hospitalet de Llobregat Barcelona, 08908, Spain
Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruna , 15006, Spain
Hospital Universitario Vall D'Hebron
Barcelona , 08035, Spain
Hospital Clinico de Barcelona
Barcelona , 08036, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Verksamheten urologi, SU/Sahlgrenska
Goteborg , 413 4, Sweden
Onkologiska kliniken, Universitetssjukhuset
Lund , 221 8, Sweden
Norrlands universitetssjukhus, Urologiska kliniken
Umea , 901 8, Sweden
Akademiska sjukhuset
Uppsala , 751 8, Sweden
Urologkliniken Akademiska Sjukhuset
Uppsala , 75185, Sweden
Centrallasarettet, Onkologkliniken
Vasteras , 721 8, Sweden
Onkologisches Institut, Inselspital Bern
Bern , 3010, Switzerland
Kantonsspital St. Gallen
St. Gallen , CH-90, Switzerland
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Taipei Veterans General Hospital
Taipei , 112, Taiwan
The Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Ross Hall Hospital
Glasgow , G52 3, United Kingdom
Post Graduate Medical School, University of Surrey
Guildford , GU2 7, United Kingdom
Guy's Hospital
London , SE1 9, United Kingdom
St. Mary's Hospital, Imperial College, Health care NHS Trust
London , W2 1N, United Kingdom
Medical Oncology, Patterson institute for Cancer Research
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

674

Study ID:

NCT00375674

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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