Kidney NeoplasmsPhase 3S-TRACNCT00375674
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
A Phase 3 study testing Sunitinib malate in people with Kidney Neoplasms, run by Pfizer at 115 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Sunitinib malate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 674 participants
- Where
- 115 sitesin 22 countries
- Study dates
- 1 Aug 2007to 7 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
115 sites in 22 countries.
115 sites in 22 countries
Germany16 sites
RWTH Aachen, Urologische Klinik
Aachen, 52074
Charite Universitaetsmedizin Berlin, Campus Charite Mitte
Berlin, 10117
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12200
Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
Bonn, 53105
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, 01307
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt, 60590
Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
Homburg/Saar, 66421
Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
Jena, 07740
Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
Lübeck, 23538
Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
München, 81377
Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
Münster, 48149
Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
Nuremberg, 90419
Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
Tübingen, 72076
Universitaetsklinikum Ulm, Urologische Universitaetsklinik
Ulm, 89075
China13 sites
Cancer Institute & Hospital, CAMS
Beijing, 100021
Department of Urology,Peking University First Hospital
Beijing, 100034
Chinese PLA General Hospital/Urology Department
Beijing, 100853
Urology Department, South-Western Hospital, 3rd Military Medical University.
Chongqing, 400038
Urology Department, Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310009
Fudan University Cancer Hospital, Department of Urology
Shanghai, Shanghai Municipality, 200032
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Department of Urology, Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Huashan Hospital Fudan University
Shanghai, 200040
The first affiliated hospital of Soochow university/Department of Urology
Suzhou, Jiangsu, 215006
Tianjin Oncology Hospital, urology department
Tianjin, 300060
The Second Hospital of Tianjin Medical University
Tianjin, 300211
United States12 sites
Emory University Hospital
Atlanta, Georgia, 30322
The Emory Clinic, Inc
Atlanta, Georgia, 30322
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600
Duke University Medical Center
Durham, North Carolina, 27710
Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
Los Angeles, California, 90095
UCLA Clark Urology Center
Los Angeles, California, 90095
Hematology and Oncology Specialists, LLC
Marrero, Louisiana, 70072
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, 70006
Intermountain Medical Center
Murray, Utah, 84107
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
France11 sites
Hopital Saint-Andre
Bordeaux, 33000
Centre Oscar Lambret
Lille, 59020
Institut Paoli-Calmettes
Marseille, 13273
CRLC Val d'Aurelle
Montpellier, 34298
Hopital Europeen Georges Pompidou
Paris, 75908
Centre Eugene Marquis
Rennes, 35042
Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau
Saint-Herblain, 44805
Hopital Civil
Strasbourg, 67091
Institut Claudius Regaud - Centre de Lutte Contre le Cancer
Toulouse, 31059
CHRU de Tours - Hopital Bretonneau
Tours, 37044
Institut Gustave Roussy / Service d'Immunotherapie
Villejuif, 94805
Poland7 sites
"Vesalius" Sp. z o.o.
Krakow, 31-108
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
Lodz, 90-549
Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
Lodz, 90-549
Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan, 60-569
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw, 02-781
Klinika Onkologii, Wojskowy Instytut Medyczny
Warsaw, 04-141
Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
Wroclaw, 50-556
Czechia6 sites
Masarykuv onkologicky ustav
Brno, 656 53
Masarykuv onkologicky ustav
Brno, 65653
Fakultni nemocnice v Motole, Klinika zobrazovacich metod
Prague, 150 06
Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
Prague, 150 06
Fakultni nemocnice v Motole, Ustav nuklearni mediciny
Prague, 150 06
Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
Ústí nad Labem, 401 13
Italy6 sites
Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
Bologna, 40138
P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
Chieti Scalo, 66013
Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
Cremona, 26100
IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
Genova, 16132
Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
Milan, 20133
Divisione di Oncologia, AORN Antonio Cardarelli
Naples, 80131
Spain6 sites
Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruña, 15006
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Hospital Clinico de Barcelona
Barcelona, 08036
Institut Catala D'Oncologia (I.C.O)
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital 12 de Octubre
Madrid, 28041
Instituto Valenciano de Oncologia
Valencia, 46009
Sweden6 sites
Verksamheten urologi, SU/Sahlgrenska
Gothenburg, 413 45
Onkologiska kliniken, Universitetssjukhuset
Lund, 221 85
Norrlands universitetssjukhus, Urologiska kliniken
Umeå, 901 85
Akademiska sjukhuset
Uppsala, 751 85
Urologkliniken Akademiska Sjukhuset
Uppsala, 75185
Centrallasarettet, Onkologkliniken
Västerås, 721 89
United Kingdom6 sites
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YH
Ross Hall Hospital
Glasgow, G52 3NQ
Post Graduate Medical School, University of Surrey
Guildford, GU2 7WG
Guy's Hospital
London, SE1 9RT
St. Mary's Hospital, Imperial College, Health care NHS Trust
London, W2 1NY
Medical Oncology, Patterson institute for Cancer Research
Manchester, M20 4BX
South Korea5 sites
National Cancer Center
Goyang-si, Gyeonggido, Korea, Republic of, 10408
Department of Internal Medicine, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Asan Medical Center
Seoul, Seoul Korea, Republic of, 05505
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi, 02841
Ireland4 sites
AMNCH Hospital
Dublin, 24
Mater Misericordiae Hospital
Dublin, 7
Beaumont Hospital
Dublin, 9
University Hospital Galway
Galway
Slovakia4 sites
Univerzitna nemocnica Bratislava
Bratislava, 833 05
Narodny Onkologicky ustav
Bratislava, 833 10
Univerzitna nemocnica Martin
Martin, 036 59
Fakultna nemocnica s poliklinikou
Žilina, 012 07
Greece2 sites
"Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
Athens, 11528
Theageneio Anticancer Hospital
Thessaloniki, 54007
Israel2 sites
Institute of Oncology, Davidoff Center
Petah Tikva, 49100
Assaf Harofeh Medical Center
Tsrifin, 70300
Switzerland2 sites
Onkologisches Institut, Inselspital Bern
Bern, 3010
Kantonsspital St. Gallen
Sankt Gallen, CH-9007
Taiwan2 sites
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, 112
Australia1 site
Monash Medical Centre - Moorabin Campus
East Bentleigh, Victoria, 3165
Colombia1 site
Instituto Nacional de Cancerologia - ESE
Bogota, Cundinamarca, 0
About this study
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
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.
- Conditions
- Kidney Neoplasms
- Being tested
- Sunitinib malate, Placebo
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib malateDrug
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.
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Sunitinib malate |
| B | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study start1 Aug 2007
- Primary completion7 Apr 2016
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375674
- Sponsor's protocol ID
- A6181109
- Other IDs
- 2006-004024-37, S-TRAC
- Acronym
- S-TRAC
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2006
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36216827Patel 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.
PubMed 33028084Ouzaid 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.
PubMed 32582758Staehler 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.
PubMed 30412222Rini 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.
PubMed 29773662George 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.
PubMed 29374054Motzer 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.
PubMed 28967554Ravaud 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.
PubMed 27718781
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00375674
- Acronym / sponsor ID
- S-TRAC / A6181109
- Conditions
- Kidney Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 7 Apr 2016 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Sunitinib malate |
| B | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunitinib malatesunitinib 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. | Drug | A |
| PlaceboPlacebo 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 | Other | B |
Primary outcome
Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review
Time frame: 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 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.
DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]
Time frame: 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 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.
9 secondary outcomes
Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Number of Participants With Tolerability Symptoms
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36216827Motzer 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.
- Derived from this study: PubMed 33028084Patel 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.
- Derived from this study: PubMed 32582758Ouzaid 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.
- Derived from this study: PubMed 30412222Staehler 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.
- Derived from this study: PubMed 29773662Rini 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.
- Derived from this study: PubMed 29374054George 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.
- Derived from this study: PubMed 28967554Motzer 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.
- Derived from this study: PubMed 27718781Ravaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
115 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sunitinib malate in people with Kidney Neoplasms, run by Pfizer at 115 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in Germany, China, United States, France, Poland and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375674, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.