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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)

Primary Purpose

Kidney Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sunitinib malate
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
  • UCLA Clark Urology Center
  • Emory University Hospital
  • The Emory Clinic, Inc
  • Hematology and Oncology Specialists, LLC
  • Hematology and Oncology Specialists, LLC
  • Memorial Sloan Kettering Cancer Center
  • The University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • Fox Chase Cancer Center
  • Carolina Urologic Research Center
  • Intermountain Medical Center
  • Monash Medical Centre - Moorabin Campus
  • Urology Department, Sun Yet-Sen University Cancer Center
  • The first affiliated hospital of Soochow university/Department of Urology
  • Fudan University Cancer Hospital, Department of Urology
  • Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
  • Department of Urology, Shanghai Changhai Hospital
  • Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
  • Cancer Institute & Hospital, CAMS
  • Department of Urology,Peking University First Hospital
  • Chinese PLA General Hospital/Urology Department
  • Urology Department, South-Western Hospital, 3rd Military Medical University.
  • Huashan Hospital Fudan University
  • Tianjin Oncology Hospital, urology department
  • The Second Hospital of Tianjin Medical University
  • Instituto Nacional de Cancerologia - ESE
  • Masarykuv onkologicky ustav
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice v Motole, Klinika zobrazovacich metod
  • Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
  • Fakultni nemocnice v Motole, Ustav nuklearni mediciny
  • Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
  • Aarhus Universitetshospital
  • Hopital Saint-Andre
  • Centre Oscar Lambret
  • Institut Paoli-Calmettes
  • CRLC Val d'Aurelle
  • Hopital Europeen Georges Pompidou
  • Centre Eugene Marquis
  • Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau
  • Hopital Civil
  • Institut Claudius Regaud - Centre de Lutte Contre le Cancer
  • CHRU de Tours - Hopital Bretonneau
  • Institut Gustave Roussy / Service d'Immunotherapie
  • RWTH Aachen, Urologische Klinik
  • Charite Universitaetsmedizin Berlin, Campus Charite Mitte
  • Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
  • Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
  • Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
  • Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
  • Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
  • Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
  • Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
  • Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
  • Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
  • Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
  • Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
  • Universitaetsklinikum Ulm, Urologische Universitaetsklinik
  • "Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
  • Theageneio Anticancer Hospital
  • AMNCH Hospital
  • Mater Misericordiae Hospital
  • Beaumont Hospital
  • University Hospital Galway
  • Institute of Oncology, Davidoff Center
  • Assaf Harofeh Medical Center
  • Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
  • P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
  • Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
  • IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
  • Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
  • Divisione di Oncologia, AORN Antonio Cardarelli
  • Department of Internal Medicine, Seoul National University Bundang Hospital
  • National Cancer Center
  • Asan Medical Center
  • Korea University Anam Hospital
  • Samsung Medical Center
  • Sarawak General Hospital
  • Torre Medica Cristobal Colon
  • "Vesalius" Sp. z o.o.
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
  • Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
  • Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • Klinika Onkologii, Wojskowy Instytut Medyczny
  • Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
  • Univerzitna nemocnica Bratislava
  • Narodny Onkologicky ustav
  • Univerzitna nemocnica Martin
  • Fakultna nemocnica s poliklinikou
  • Institut Catala D'Oncologia (I.C.O)
  • Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
  • Hospital Universitario Vall D'Hebron
  • Hospital Clinico de Barcelona
  • Hospital 12 de Octubre
  • Instituto Valenciano de Oncologia
  • Verksamheten urologi, SU/Sahlgrenska
  • Onkologiska kliniken, Universitetssjukhuset
  • Norrlands universitetssjukhus, Urologiska kliniken
  • Akademiska sjukhuset
  • Urologkliniken Akademiska Sjukhuset
  • Centrallasarettet, Onkologkliniken
  • Onkologisches Institut, Inselspital Bern
  • Kantonsspital St. Gallen
  • Taichung Veterans General Hospital
  • Taipei Veterans General Hospital
  • The Beatson West of Scotland Cancer Centre
  • Ross Hall Hospital
  • Post Graduate Medical School, University of Surrey
  • Guy's Hospital
  • St. Mary's Hospital, Imperial College, Health care NHS Trust
  • Medical Oncology, Patterson institute for Cancer Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
September 12, 2006
Last Updated
August 22, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00375674
Brief Title
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Acronym
S-TRAC
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2007 (Actual)
Primary Completion Date
April 7, 2016 (Actual)
Study Completion Date
September 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
674 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sunitinib malate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review
Description
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.
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.
Title
DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]
Description
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.
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
Secondary Outcome Measure Information:
Title
Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)
Description
OS was defined as the time from the date of randomization to the date of death due to any cause.
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)
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Description
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.
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
Title
Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)
Description
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.
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
Title
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
Description
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.
Time Frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Title
PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison
Description
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.
Time Frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Title
PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison
Description
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.
Time Frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Title
PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population
Description
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.
Time Frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Title
PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means
Description
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).
Time Frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Title
Number of Participants With Tolerability Symptoms
Description
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.
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

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33028084
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.
Results Reference
derived
PubMed Identifier
32582758
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.
Results Reference
derived
PubMed Identifier
30412222
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.
Results Reference
derived
PubMed Identifier
29773662
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.
Results Reference
derived
PubMed Identifier
29374054
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.
Results Reference
derived
PubMed Identifier
28967554
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.
Results Reference
derived
PubMed Identifier
27718781
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181109&StudyName=A%20Clinical%20Trial%20Comparing%20Efficacy%20And%20Safety%20Of%20Sunitinib%20Versus%20Placebo%20For%20TheTreatment%20Of%20Patients%20At%20High%20Risk%20Of%20Recurrent%20Rena
Description
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Learn more about this trial

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

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