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

Kidney Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375674
• Other study ID #: A6181109
• Secondary ID: 2006-004024-37S-
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2007
• Est. completion date: September 7, 2017

Study information

• Verified date: August 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: September 7, 2017
• Est. primary completion date: April 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Drug:
• Sunitinib malate
sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.

Other:
• Placebo
Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent

Locations

Country	Name	City	State
Australia	Monash Medical Centre - Moorabin Campus	East Bentleigh	Victoria
China	Cancer Institute & Hospital, CAMS	Beijing
China	Chinese PLA General Hospital/Urology Department	Beijing
China	Department of Urology,Peking University First Hospital	Beijing
China	Urology Department, South-Western Hospital, 3rd Military Medical University.	Chongqing
China	Urology Department, Sun Yet-Sen University Cancer Center	Guangzhou	Guangdong
China	Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	Department of Urology, Shanghai Changhai Hospital	Shanghai	Shanghai
China	Fudan University Cancer Hospital, Department of Urology	Shanghai	Shanghai
China	Huashan Hospital Fudan University	Shanghai
China	Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The first affiliated hospital of Soochow university/Department of Urology	Suzhou	Jiangsu
China	The Second Hospital of Tianjin Medical University	Tianjin
China	Tianjin Oncology Hospital, urology department	Tianjin
Colombia	Instituto Nacional de Cancerologia - ESE	Bogota	Cundinamarca
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice v Motole, Klinika zobrazovacich metod	Praha 5
Czechia	Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni	Praha 5
Czechia	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
Denmark	Aarhus Universitetshospital	Aarhus C
France	Hopital Saint-Andre	Bordeaux
France	Centre Oscar Lambret	Lille
France	Institut Paoli-Calmettes	Marseille Cedex 09
France	CRLC Val d'Aurelle	MONTPELLIER Cedex 5
France	Hopital Europeen Georges Pompidou	Paris Cedex 15
France	Centre Eugene Marquis	Rennes
France	Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau	Saint Herblain
France	Hopital Civil	Strasbourg
France	Institut Claudius Regaud - Centre de Lutte Contre le Cancer	Toulouse Cedex 9
France	CHRU de Tours - Hopital Bretonneau	Tours Cedex 1
France	Institut Gustave Roussy / Service d'Immunotherapie	Villejuif Cedex
Germany	RWTH Aachen, Urologische Klinik	Aachen
Germany	Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Charite Universitaetsmedizin Berlin, Campus Charite Mitte	Berlin
Germany	Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie	Bonn
Germany	Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden	Dresden
Germany	Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II	Frankfurt
Germany	Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie	Homburg/Saar
Germany	Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie	Jena
Germany	Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck	Luebeck
Germany	Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik	Muenchen
Germany	Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie	Muenster
Germany	Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie	Nuernberg
Germany	Eberhardt-Karls-Universität Tübingen, Klinik für Urologie	Tuebingen
Germany	Universitaetsklinikum Ulm, Urologische Universitaetsklinik	Ulm
Greece	"Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit	Athens
Greece	Theageneio Anticancer Hospital	Thessaloniki
Ireland	AMNCH Hospital	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae Hospital	Dublin
Ireland	University Hospital Galway	Galway
Israel	Institute of Oncology, Davidoff Center	Petach-Tikva
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi	Bologna
Italy	P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica	Chieti Scalo
Italy	Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona	Cremona
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	Divisione di Oncologia, AORN Antonio Cardarelli	Napoli
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggido, Korea, Republic OF
Korea, Republic of	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	Samsung Medical Center	Seoul
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Mexico	Torre Medica Cristobal Colon	Acapulco	Gro.
Poland	"Vesalius" Sp. z o.o.	Krakow
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A	Lodz
Poland	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	Klinika Onkologii, Wojskowy Instytut Medyczny	Warszawa
Poland	Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny	Wroclaw
Slovakia	Narodny Onkologicky ustav	Bratislava
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	Univerzitna nemocnica Martin	Martin
Slovakia	Fakultna nemocnica s poliklinikou	Zilina
Spain	Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera	A Coruna
Spain	Hospital Clinico de Barcelona	Barcelona
Spain	Hospital Universitario Vall D'Hebron	Barcelona
Spain	Institut Catala D'Oncologia (I.C.O)	L'hospitalet de Llobregat	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Instituto Valenciano de Oncologia	Valencia
Sweden	Verksamheten urologi, SU/Sahlgrenska	Goteborg
Sweden	Onkologiska kliniken, Universitetssjukhuset	Lund
Sweden	Norrlands universitetssjukhus, Urologiska kliniken	Umea
Sweden	Akademiska sjukhuset	Uppsala
Sweden	Urologkliniken Akademiska Sjukhuset	Uppsala
Sweden	Centrallasarettet, Onkologkliniken	Vasteras
Switzerland	Onkologisches Institut, Inselspital Bern	Bern
Switzerland	Kantonsspital St. Gallen	St. Gallen
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Ross Hall Hospital	Glasgow
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Post Graduate Medical School, University of Surrey	Guildford
United Kingdom	Guy's Hospital	London
United Kingdom	St. Mary's Hospital, Imperial College, Health care NHS Trust	London
United Kingdom	Medical Oncology, Patterson institute for Cancer Research	Manchester
United States	Emory University Hospital	Atlanta	Georgia
United States	The Emory Clinic, Inc	Atlanta	Georgia
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services	Los Angeles	California
United States	UCLA Clark Urology Center	Los Angeles	California
United States	Hematology and Oncology Specialists, LLC	Marrero	Louisiana
United States	Hematology and Oncology Specialists, LLC	Metairie	Louisiana
United States	Intermountain Medical Center	Murray	Utah
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  China,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review	DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.	Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.
Primary	DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]	DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites.; Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses.; Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent.; According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.	Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later
Secondary	Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)	OS was defined as the time from the date of randomization to the date of death due to any cause.	Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity	TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.; Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.	Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
Secondary	Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)	TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.; Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later.; The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.	Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
Secondary	Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale, 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning & symptoms; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL & more severe for symptoms.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary	PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale & 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary	PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison	PROs assessed health-related QoL by using the EORTC QLQ-C30, which was a 30 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary	PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, & anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, & 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from -0.594 to 1; low scores represented a higher level of dysfunction & 1 as perfect health.	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary	PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means	Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
Secondary	Number of Participants With Tolerability Symptoms	Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later.; The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row.	Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later

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