Clinical trial NCT00375674: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Official title: Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review
timeFrame: Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.
measure: DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]
timeFrame: Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later
Secondary outcomes:
measure: Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)
timeFrame: Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
timeFrame: Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
measure: Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)
timeFrame: Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
measure: Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores
timeFrame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
measure: PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison
timeFrame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
measure: PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison
timeFrame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
measure: PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population
timeFrame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
measure: PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means
timeFrame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
measure: Number of Participants With Tolerability Symptoms
timeFrame: Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
state: California
city: Los Angeles
country: United States
facility: UCLA Clark Urology Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic, Inc
state: Georgia
city: Marrero
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Metairie
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: East Bentleigh
country: Australia
facility: Monash Medical Centre - Moorabin Campus
state: Victoria
city: Guangzhou
country: China
facility: Urology Department, Sun Yet-Sen University Cancer Center
state: Guangdong
city: Suzhou
country: China
facility: The first affiliated hospital of Soochow university/Department of Urology
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Cancer Hospital, Department of Urology
state: Shanghai
city: Shanghai
country: China
facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Urology, Shanghai Changhai Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Cancer Institute & Hospital, CAMS
city: Beijing
country: China
facility: Department of Urology,Peking University First Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital/Urology Department
city: Chongqing
country: China
facility: Urology Department, South-Western Hospital, 3rd Military Medical University.
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Tianjin
country: China
facility: Tianjin Oncology Hospital, urology department
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia - ESE
state: Cundinamarca
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole, Klinika zobrazovacich metod
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole, Ustav nuklearni mediciny
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
city: Aarhus C
country: Denmark
facility: Aarhus Universitetshospital
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille Cedex 09
country: France
facility: Institut Paoli-Calmettes
city: MONTPELLIER Cedex 5
country: France
facility: CRLC Val d'Aurelle
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau
city: Strasbourg
country: France
facility: Hopital Civil
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud - Centre de Lutte Contre le Cancer
city: Tours Cedex 1
country: France
facility: CHRU de Tours - Hopital Bretonneau
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy / Service d'Immunotherapie
city: Aachen
country: Germany
facility: RWTH Aachen, Urologische Klinik
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Campus Charite Mitte
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
city: Frankfurt
country: Germany
facility: Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
city: Luebeck
country: Germany
facility: Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
city: Muenchen
country: Germany
facility: Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
city: Tuebingen
country: Germany
facility: Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm, Urologische Universitaetsklinik
city: Athens
country: Greece
facility: "Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Hospital
city: Dublin
country: Ireland
facility: AMNCH Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Petach-Tikva
country: Israel
facility: Institute of Oncology, Davidoff Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bologna
country: Italy
facility: Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
city: Chieti Scalo
country: Italy
facility: P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
city: Cremona
country: Italy
facility: Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
city: Genova
country: Italy
facility: IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
city: Milano
country: Italy
facility: Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
city: Napoli
country: Italy
facility: Divisione di Oncologia, AORN Antonio Cardarelli
city: Seongnam-si
country: Korea, Republic of
facility: Department of Internal Medicine, Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggido, Korea, Republic OF
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Korea, Republic OF
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Acapulco
country: Mexico
facility: Torre Medica Cristobal Colon
state: Gro.
city: Krakow
country: Poland
facility: "Vesalius" Sp. z o.o.
city: Lodz
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
city: Poznan
country: Poland
facility: Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Klinika Onkologii, Wojskowy Instytut Medyczny
city: Wroclaw
country: Poland
facility: Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky ustav
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Zilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou
city: L'hospitalet de Llobregat
country: Spain
facility: Institut Catala D'Oncologia (I.C.O)
state: Barcelona
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Goteborg
country: Sweden
facility: Verksamheten urologi, SU/Sahlgrenska
city: Lund
country: Sweden
facility: Onkologiska kliniken, Universitetssjukhuset
city: Umea
country: Sweden
facility: Norrlands universitetssjukhus, Urologiska kliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Uppsala
country: Sweden
facility: Urologkliniken Akademiska Sjukhuset
city: Vasteras
country: Sweden
facility: Centrallasarettet, Onkologkliniken
city: Bern
country: Switzerland
facility: Onkologisches Institut, Inselspital Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Glasgow
country: United Kingdom
facility: Ross Hall Hospital
city: Guildford
country: United Kingdom
facility: Post Graduate Medical School, University of Surrey
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital, Imperial College, Health care NHS Trust
city: Manchester
country: United Kingdom
facility: Medical Oncology, Patterson institute for Cancer Research
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.