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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Neoplasms
• Intervention / Treatment: Drug: Sunitinib malate; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 674
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Bentleigh, Victoria, Australia, 3165
      • Monash Medical Centre - Moorabin Campus
• China
  • Beijing, China, 100034
    • Department of Urology,Peking University First Hospital
  • Beijing, China, 100021
    • Cancer Institute & Hospital, CAMS
  • Beijing, China, 100853
    • Chinese PLA General Hospital/Urology Department
  • Chongqing, China, 400038
    • Urology Department, South-Western Hospital, 3rd Military Medical University.
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
  • Tianjin, China, 300211
    • The Second Hospital Of Tianjin Medical University
  • Tianjin, China, 300060
    • Tianjin Oncology Hospital, urology department
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Urology Department, Sun Yet-Sen University Cancer Center
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The first affiliated hospital of Soochow university/Department of Urology
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Hospital, Department of Urology
    • Shanghai, Shanghai, China, 200433
      • Department of Urology, Shanghai Changhai Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Instituto Nacional de Cancerologia - ESE
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav
  • Brno, Czechia, 65653
    • Masarykuv onkologicky ustav
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole, Klinika zobrazovacich metod
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole, Ustav nuklearni mediciny
  • Usti nad Labem, Czechia, 401 13
    • Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus Universitetshospital
• France
  • Bordeaux, France, 33000
    • Hôpital Saint-André
  • Lille, France, 59020
    • Centre Oscar Lambret
  • MONTPELLIER Cedex 5, France, 34298
    • CRLC Val d'Aurelle
  • Marseille Cedex 09, France, 13273
    • Institut Paoli-Calmettes
  • Paris Cedex 15, France, 75908
    • Hôpital Européen Georges Pompidou
  • Rennes, France, 35042
    • Centre Eugene Marquis
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Strasbourg, France, 67091
    • Hôpital Civil
  • Toulouse Cedex 9, France, 31059
    • Institut Claudius Regaud - Centre de Lutte Contre le Cancer
  • Tours Cedex 1, France, 37044
    • CHRU de Tours - Hôpital Bretonneau
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy / Service d'Immunotherapie
• Germany
  • Aachen, Germany, 52074
    • RWTH Aachen, Urologische Klinik
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin, Campus Charité Mitte
  • Berlin, Germany, 12200
    • Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
  • Bonn, Germany, 53105
    • Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
  • Frankfurt, Germany, 60590
    • Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Homburg/Saar, Germany, 66421
    • Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
  • Jena, Germany, 07740
    • Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
  • Luebeck, Germany, 23538
    • Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
  • Muenchen, Germany, 81377
    • Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
  • Nuernberg, Germany, 90419
    • Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
  • Tuebingen, Germany, 72076
    • Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
  • Ulm, Germany, 89075
    • Universitaetsklinikum Ulm, Urologische Universitaetsklinik
• Greece
  • Athens, Greece, 11528
    • "Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
  • Thessaloniki, Greece, 54007
    • Theageneio Anticancer Hospital
• Ireland
  • Dublin, Ireland, 9
    • Beaumont Hospital
  • Dublin, Ireland, 7
    • Mater Misericordiae Hospital
  • Dublin, Ireland, 24
    • AMNCH Hospital
  • Galway, Ireland
    • University Hospital Galway
• Israel
  • Petach-Tikva, Israel, 49100
    • Institute of Oncology, Davidoff Center
  • Zerifin, Israel, 70300
    • Assaf Harofeh Medical Center
• Italy
  • Bologna, Italy, 40138
    • Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
  • Chieti Scalo, Italy, 66013
    • P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
  • Cremona, Italy, 26100
    • Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
  • Genova, Italy, 16132
    • IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
  • Milano, Italy, 20133
    • Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
  • Napoli, Italy, 80131
    • Divisione di Oncologia, AORN Antonio Cardarelli
• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Department of Internal Medicine, Seoul National University Bundang Hospital
  • Gyeonggido, Korea, Republic OF
    • Goyang-si, Gyeonggido, Korea, Republic OF, Korea, Republic of, 10408
      • National Cancer Center
  • Seoul Korea, Republic OF
    • Seoul, Seoul Korea, Republic OF, Korea, Republic of, 05505
      • Asan Medical Center
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
      • Korea University Anam Hospital
• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital
• Mexico
  • Gro.
    • Acapulco, Gro., Mexico, 39670
      • Torre Medica Cristobal Colon
• Poland
  • Krakow, Poland, 31-108
    • "Vesalius" Sp. z o.o.
  • Lodz, Poland, 90-549
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
  • Lodz, Poland, 90-549
    • Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
  • Poznan, Poland, 60-569
    • Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • Warszawa, Poland, 04-141
    • Klinika Onkologii, Wojskowy Instytut Medyczny
  • Wroclaw, Poland, 50-556
    • Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny onkologicky ustav
  • Bratislava, Slovakia, 833 05
    • Univerzitna nemocnica Bratislava
  • Martin, Slovakia, 036 59
    • Univerzitná nemocnica Martin
  • Zilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou
• Spain
  • A Coruna, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clínico de Barcelona
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Barcelona
    • L'hospitalet de Llobregat, Barcelona, Spain, 08908
      • Institut Catala D'Oncologia (I.C.O)
• Sweden
  • Goteborg, Sweden, 413 45
    • Verksamheten urologi, SU/Sahlgrenska
  • Lund, Sweden, 221 85
    • Onkologiska kliniken, Universitetssjukhuset
  • Umea, Sweden, 901 85
    • Norrlands universitetssjukhus, Urologiska kliniken
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
  • Uppsala, Sweden, 75185
    • Urologkliniken Akademiska Sjukhuset
  • Vasteras, Sweden, 721 89
    • Centrallasarettet, Onkologkliniken
• Switzerland
  • Bern, Switzerland, 3010
    • Onkologisches Institut, Inselspital Bern
  • St. Gallen, Switzerland, CH-9007
    • Kantonsspital St. Gallen
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
• United Kingdom
  • Glasgow, United Kingdom, G12 0YH
    • The Beatson West of Scotland Cancer Centre
  • Glasgow, United Kingdom, G52 3NQ
    • Ross Hall Hospital
  • Guildford, United Kingdom, GU2 7WG
    • Post Graduate Medical School, University of Surrey
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, W2 1NY
    • St. Mary's Hospital, Imperial College, Health care NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • Medical Oncology, Patterson institute for Cancer Research
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Clark Urology Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic, Inc
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Hematology And Oncology Specialists, Llc
    • Metairie, Louisiana, United States, 70006
      • Hematology And Oncology Specialists, Llc
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7600
      • The University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	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.
Placebo Comparator: B	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review	DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.	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.
DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]	DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)	OS was defined as the time from the date of randomization to the date of death due to any cause.	Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity	TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs. Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.	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
Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)	TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs. Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.	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
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	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale, 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning & symptoms; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL & more severe for symptoms.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale & 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison	PROs assessed health-related QoL by using the EORTC QLQ-C30, which was a 30 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, & anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, & 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from -0.594 to 1; low scores represented a higher level of dysfunction & 1 as perfect health.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Number of Participants With Tolerability Symptoms	Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row.	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): April 7, 2016
• Study Completion (Actual): September 7, 2017

Study Registration Dates

• First Submitted: September 12, 2006
• First Submitted That Met QC Criteria: September 12, 2006
• First Posted (Estimate): September 13, 2006

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181109; 2006-004024-37 (EudraCT Number); S-TRAC (Other Identifier: Alias Study Number)