A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
- Registration Number
- NCT00375674
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 674
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo - A Sunitinib malate -
- Primary Outcome Measures
Name Time Method Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent.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for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent.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] 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population) Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months) 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 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 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) 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 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 Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year) 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 Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year) 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 Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year) 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 Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year) 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 Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year) 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 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 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.
Trial Locations
- Locations (113)
Instituto Nacional de Cancerologia - ESE
🇨🇴Bogota, Cundinamarca, Colombia
Beaumont Hospital
🇮🇪Dublin, Ireland
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow
🇵🇱Lodz, Poland
Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
🇵🇱Poznan, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Fakultna nemocnica s poliklinikou
🇸🇰Zilina, Slovakia
Cancer Institute & Hospital, CAMS
🇨🇳Beijing, China
Urology Department, South-Western Hospital, 3rd Military Medical University.
🇨🇳Chongqing, China
Tianjin Oncology Hospital, urology department
🇨🇳Tianjin, China
The Emory Clinic, Inc
🇺🇸Atlanta, Georgia, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Department of Urology, Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Chinese PLA General Hospital/Urology Department
🇨🇳Beijing, China
Huashan Hospital Fudan University
🇨🇳Shanghai, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, China
Fakultni nemocnice v Motole, Ustav nuklearni mediciny
🇨🇿Praha 5, Czechia
Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.
🇨🇿Usti nad Labem, Czechia
Institut Claudius Regaud - Centre de Lutte Contre le Cancer
🇫🇷Toulouse Cedex 9, France
Mater Misericordiae Hospital
🇮🇪Dublin, Ireland
"Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit
🇬🇷Athens, Greece
Department of Internal Medicine, Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul Korea, Republic OF, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Klinika Onkologii, Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Hospital Clinico de Barcelona
🇪🇸Barcelona, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Ross Hall Hospital
🇬🇧Glasgow, United Kingdom
Post Graduate Medical School, University of Surrey
🇬🇧Guildford, United Kingdom
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
St. Mary's Hospital, Imperial College, Health care NHS Trust
🇬🇧London, United Kingdom
Medical Oncology, Patterson institute for Cancer Research
🇬🇧Manchester, United Kingdom
Aarhus Universitetshospital
🇩🇰Aarhus C, Denmark
Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona
🇮🇹Cremona, Italy
Universitaetsklinikum Ulm, Urologische Universitaetsklinik
🇩🇪Ulm, Germany
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Monash Medical Centre - Moorabin Campus
🇦🇺East Bentleigh, Victoria, Australia
UCLA Clark Urology Center
🇺🇸Los Angeles, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Hematology and Oncology Specialists, LLC
🇺🇸Metairie, Louisiana, United States
Fudan University Cancer Hospital, Department of Urology
🇨🇳Shanghai, Shanghai, China
Department of Urology,Peking University First Hospital
🇨🇳Beijing, China
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
🇺🇸Los Angeles, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Urology Department, Sun Yet-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine
🇨🇳Hangzhou, Zhejiang, China
The first affiliated hospital of Soochow university/Department of Urology
🇨🇳Suzhou, Jiangsu, China
Fakultni nemocnice v Motole, Klinika zobrazovacich metod
🇨🇿Praha 5, Czechia
Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni
🇨🇿Praha 5, Czechia
Hopital Saint-Andre
🇫🇷Bordeaux, France
Institut Paoli-Calmettes
🇫🇷Marseille Cedex 09, France
Centre Eugene Marquis
🇫🇷Rennes, France
Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie
🇩🇪Nuernberg, Germany
Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie
🇩🇪Bonn, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Hopital Civil
🇫🇷Strasbourg, France
CHRU de Tours - Hopital Bretonneau
🇫🇷Tours Cedex 1, France
Centre Oscar Lambret
🇫🇷Lille, France
CRLC Val d'Aurelle
🇫🇷MONTPELLIER Cedex 5, France
Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck
🇩🇪Luebeck, Germany
Theageneio Anticancer Hospital
🇬🇷Thessaloniki, Greece
AMNCH Hospital
🇮🇪Dublin, Ireland
Institute of Oncology, Davidoff Center
🇮🇱Petach-Tikva, Israel
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Hopital Europeen Georges Pompidou
🇫🇷Paris Cedex 15, France
Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau
🇫🇷Saint Herblain, France
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
🇩🇪Frankfurt, Germany
Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie
🇩🇪Muenster, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
🇩🇪Dresden, Germany
University Hospital Galway
🇮🇪Galway, Ireland
Charite Universitaetsmedizin Berlin, Campus Charite Mitte
🇩🇪Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie
🇩🇪Hamburg, Germany
Institut Gustave Roussy / Service d'Immunotherapie
🇫🇷Villejuif Cedex, France
Eberhardt-Karls-Universität Tübingen, Klinik für Urologie
🇩🇪Tuebingen, Germany
RWTH Aachen, Urologische Klinik
🇩🇪Aachen, Germany
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
🇩🇪Homburg/Saar, Germany
Torre Medica Cristobal Colon
🇲🇽Acapulco, Gro., Mexico
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A
🇵🇱Lodz, Poland
Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genova, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
🇮🇹Milano, Italy
P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica
🇮🇹Chieti Scalo, Italy
Divisione di Oncologia, AORN Antonio Cardarelli
🇮🇹Napoli, Italy
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
"Vesalius" Sp. z o.o.
🇵🇱Krakow, Poland
National Cancer Center
🇰🇷Goyang-si, Gyeonggido, Korea, Republic OF, Korea, Republic of
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Onkologiska kliniken, Universitetssjukhuset
🇸🇪Lund, Sweden
Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny
🇵🇱Wroclaw, Poland
Norrlands universitetssjukhus, Urologiska kliniken
🇸🇪Umea, Sweden
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Urologkliniken Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Centrallasarettet, Onkologkliniken
🇸🇪Vasteras, Sweden
Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Institut Catala D'Oncologia (I.C.O)
🇪🇸L'hospitalet de Llobregat, Barcelona, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Narodny Onkologicky ustav
🇸🇰Bratislava, Slovakia
Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
🇪🇸A Coruna, Spain
Onkologisches Institut, Inselspital Bern
🇨🇭Bern, Switzerland
Verksamheten urologi, SU/Sahlgrenska
🇸🇪Goteborg, Sweden
Hospital Universitario Vall D'Hebron
🇪🇸Barcelona, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
🇩🇪Muenchen, Germany
Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie
🇩🇪Jena, Germany
Guy's Hospital
🇬🇧London, United Kingdom