A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
NCT ID: NCT00375674
Last Updated: 2018-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
674 participants
INTERVENTIONAL
2007-08-01
2017-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
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.
B
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
Los Angeles, California, United States
UCLA Clark Urology Center
Los Angeles, California, United States
Emory University Hospital
Atlanta, Georgia, United States
The Emory Clinic, Inc
Atlanta, Georgia, United States
Hematology and Oncology Specialists, LLC
Marrero, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Intermountain Medical Center
Murray, Utah, United States
Monash Medical Centre - Moorabin Campus
East Bentleigh, Victoria, Australia
Urology Department, Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, China
The first affiliated hospital of Soochow university/Department of Urology
Suzhou, Jiangsu, China
Fudan University Cancer Hospital, Department of Urology
Shanghai, Shanghai Municipality, China
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Urology, Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, China
Cancer Institute & Hospital, CAMS
Beijing, , China
Department of Urology,Peking University First Hospital
Beijing, , China
Chinese PLA General Hospital/Urology Department
Beijing, , China
Urology Department, South-Western Hospital, 3rd Military Medical University.
Chongqing, , China
Huashan Hospital Fudan University
Shanghai, , China
Tianjin Oncology Hospital, urology department
Tianjin, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Instituto Nacional de Cancerologia - ESE
Bogota, Cundinamarca, Colombia
Masarykuv onkologicky ustav
Brno, , Czechia
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice v Motole, Klinika zobrazovacich metod
Prague, , Czechia
Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
Prague, , Czechia
Fakultni nemocnice v Motole, Ustav nuklearni mediciny
Prague, , Czechia
Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
Ústí nad Labem, , Czechia
Aarhus Universitetshospital
Aarhus C, , Denmark
Hopital Saint-Andre
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
CRLC Val d'Aurelle
Montpellier, , France
Hopital Europeen Georges Pompidou
Paris, , France
Centre Eugene Marquis
Rennes, , France
Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau
Saint-Herblain, , France
Hopital Civil
Strasbourg, , France
Institut Claudius Regaud - Centre de Lutte Contre le Cancer
Toulouse, , France
CHRU de Tours - Hopital Bretonneau
Tours, , France
Institut Gustave Roussy / Service d'Immunotherapie
Villejuif, , France
RWTH Aachen, Urologische Klinik
Aachen, , Germany
Charite Universitaetsmedizin Berlin, Campus Charite Mitte
Berlin, , Germany
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
Bonn, , Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, , Germany
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
Homburg/Saar, , Germany
Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
Jena, , Germany
Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
Lübeck, , Germany
Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
München, , Germany
Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
Münster, , Germany
Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
Nuremberg, , Germany
Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
Tübingen, , Germany
Universitaetsklinikum Ulm, Urologische Universitaetsklinik
Ulm, , Germany
"Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
Athens, , Greece
Theageneio Anticancer Hospital
Thessaloniki, , Greece
AMNCH Hospital
Dublin, , Ireland
Mater Misericordiae Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Institute of Oncology, Davidoff Center
Petah Tikva, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
Bologna, , Italy
P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
Chieti Scalo, , Italy
Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
Cremona, , Italy
IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
Genova, , Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
Milan, , Italy
Divisione di Oncologia, AORN Antonio Cardarelli
Napoli, , Italy
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Torre Medica Cristobal Colon
Acapulco de Juárez, Guerrero, Mexico
"Vesalius" Sp. z o.o.
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
Lodz, , Poland
Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
Lodz, , Poland
Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Klinika Onkologii, Wojskowy Instytut Medyczny
Warsaw, , Poland
Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
Wroclaw, , Poland
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Narodny Onkologicky ustav
Bratislava, , Slovakia
Univerzitna nemocnica Martin
Martin, , Slovakia
Fakultna nemocnica s poliklinikou
Žilina, , Slovakia
Department of Internal Medicine, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, Gyeonggido, Korea, Republic of, South Korea
Samsung Medical Center
Seoul, Korea, Republic of, South Korea
Asan Medical Center
Seoul, Seoul Korea, Republic of, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Institut Catala D'Oncologia (I.C.O)
L'Hospitalet de Llobregat, Barcelona, Spain
Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruña, , Spain
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Hospital Clinico de Barcelona
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Verksamheten urologi, SU/Sahlgrenska
Gothenburg, , Sweden
Onkologiska kliniken, Universitetssjukhuset
Lund, , Sweden
Norrlands universitetssjukhus, Urologiska kliniken
Umeå, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Urologkliniken Akademiska Sjukhuset
Uppsala, , Sweden
Centrallasarettet, Onkologkliniken
Västerås, , Sweden
Onkologisches Institut, Inselspital Bern
Bern, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Ross Hall Hospital
Glasgow, , United Kingdom
Post Graduate Medical School, University of Surrey
Guildford, , United Kingdom
Guy's Hospital
London, , United Kingdom
St. Mary's Hospital, Imperial College, Health care NHS Trust
London, , United Kingdom
Medical Oncology, Patterson institute for Cancer Research
Manchester, , United Kingdom
Countries
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References
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Motzer RJ, Martini JF, Mu XJ, Staehler M, George DJ, Valota O, Lin X, Pandha HS, Ching KA, Ravaud A. Molecular characterization of renal cell carcinoma tumors from a phase III anti-angiogenic adjuvant therapy trial. Nat Commun. 2022 Oct 10;13(1):5959. doi: 10.1038/s41467-022-33555-8.
Patel A, Ravaud A, Motzer RJ, Pantuck AJ, Staehler M, Escudier B, Martini JF, Lechuga M, Lin X, George DJ. Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting. Future Oncol. 2021 Feb;17(4):403-409. doi: 10.2217/fon-2020-0652. Epub 2020 Oct 8.
Ouzaid I, Kammerer-Jacquet SF, Khene Z, Ravaud A, Patard JJ, Bensalah K, Rioux-Leclercq N. Exploring Biological Predictive Factors of Progression After Surgery in High-Risk Renal Cell Carcinoma: Results From the French Cohort of the Randomized S-TRAC Trial Patients. Front Surg. 2020 Jun 5;7:26. doi: 10.3389/fsurg.2020.00026. eCollection 2020.
Staehler M, Motzer RJ, George DJ, Pandha HS, Donskov F, Escudier B, Pantuck AJ, Patel A, DeAnnuntis L, Bhattacharyya H, Ramaswamy K, Zanotti G, Lin X, Lechuga M, Serfass L, Paty J, Ravaud A. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial. Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.
Rini BI, Escudier B, Martini JF, Magheli A, Svedman C, Lopatin M, Knezevic D, Goddard AD, Febbo PG, Li R, Lin X, Valota O, Staehler M, Motzer RJ, Ravaud A. Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib. Clin Cancer Res. 2018 Sep 15;24(18):4407-4415. doi: 10.1158/1078-0432.CCR-18-0323. Epub 2018 May 17.
George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Escudier B, Gerletti P, Li S, Casey M, Laguerre B, Pandha HS, Pantuck AJ, Patel A, Lechuga MJ, Ravaud A. Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study. Clin Cancer Res. 2018 Apr 1;24(7):1554-1561. doi: 10.1158/1078-0432.CCR-17-2822. Epub 2018 Jan 26.
Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results. Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.
Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. doi: 10.1056/NEJMoa1611406. Epub 2016 Oct 9.
Other Identifiers
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2006-004024-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S-TRAC
Identifier Type: OTHER
Identifier Source: secondary_id
A6181109
Identifier Type: -
Identifier Source: org_study_id
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