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

NCT00375674 | Completed Phase 3 Results DMC

• 3 other identifiers: A61811092006-004024-37S-TRAC
• Study Type: interventional
• Target: 674
• Locations: 22 countries
• Sites: 115

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.

Conditions

Kidney Neoplasms

Outcome Measures

Primary Outcomes (2)

• Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review

  DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.

  Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.

• DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]

  DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.

  Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later

Secondary Outcomes (9)

• 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)

• 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

• 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

• 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)

• 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)

Study Arms (2)

A

EXPERIMENTAL

Drug: Sunitinib malate

B

PLACEBO COMPARATOR

Other: Placebo

Interventions

Sunitinib malate DRUG

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.

A

Placebo OTHER

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (115)

Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services

Los Angeles, California, 90095, United States

Location

UCLA Clark Urology Center

Los Angeles, California, 90095, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

The Emory Clinic, Inc

Atlanta, Georgia, 30322, United States

Location

Hematology and Oncology Specialists, LLC

Marrero, Louisiana, 70072, United States

Location

Hematology and Oncology Specialists, LLC

Metairie, Louisiana, 70006, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7600, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Monash Medical Centre - Moorabin Campus

East Bentleigh, Victoria, 3165, Australia

Location

Urology Department, Sun Yet-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

The first affiliated hospital of Soochow university/Department of Urology

Suzhou, Jiangsu, 215006, China

Location

Fudan University Cancer Hospital, Department of Urology

Shanghai, Shanghai Municipality, 200032, China

Location

Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Department of Urology, Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Cancer Institute & Hospital, CAMS

Beijing, 100021, China

Location

Department of Urology,Peking University First Hospital

Beijing, 100034, China

Location

Chinese PLA General Hospital/Urology Department

Beijing, 100853, China

Location

Urology Department, South-Western Hospital, 3rd Military Medical University.

Chongqing, 400038, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Tianjin Oncology Hospital, urology department

Tianjin, 300060, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, 300211, China

Location

Instituto Nacional de Cancerologia - ESE

Bogota, Cundinamarca, 0, Colombia

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Masarykuv onkologicky ustav

Brno, 65653, Czechia

Location

Fakultni nemocnice v Motole, Klinika zobrazovacich metod

Prague, 150 06, Czechia

Location

Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni

Prague, 150 06, Czechia

Location

Fakultni nemocnice v Motole, Ustav nuklearni mediciny

Prague, 150 06, Czechia

Location

Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.

Ústí nad Labem, 401 13, Czechia

Location

Aarhus Universitetshospital

Aarhus C, 8000, Denmark

Location

Hopital Saint-Andre

Bordeaux, 33000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

CRLC Val d'Aurelle

Montpellier, 34298, France

Location

Hopital Europeen Georges Pompidou

Paris, 75908, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau

Saint-Herblain, 44805, France

Location

Hopital Civil

Strasbourg, 67091, France

Location

Institut Claudius Regaud - Centre de Lutte Contre le Cancer

Toulouse, 31059, France

Location

CHRU de Tours - Hopital Bretonneau

Tours, 37044, France

Location

Institut Gustave Roussy / Service d'Immunotherapie

Villejuif, 94805, France

Location

RWTH Aachen, Urologische Klinik

Aachen, 52074, Germany

Location

Charite Universitaetsmedizin Berlin, Campus Charite Mitte

Berlin, 10117, Germany

Location

Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie

Bonn, 53105, Germany

Location

Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

Dresden, 01307, Germany

Location

Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II

Frankfurt, 60590, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie

Homburg/Saar, 66421, Germany

Location

Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie

Jena, 07740, Germany

Location

Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck

Lübeck, 23538, Germany

Location

Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

München, 81377, Germany

Location

Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie

Münster, 48149, Germany

Location

Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie

Nuremberg, 90419, Germany

Location

Eberhardt-Karls-Universität Tübingen, Klinik für Urologie

Tübingen, 72076, Germany

Location

Universitaetsklinikum Ulm, Urologische Universitaetsklinik

Ulm, 89075, Germany

Location

"Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit

Athens, 11528, Greece

Location

Theageneio Anticancer Hospital

Thessaloniki, 54007, Greece

Location

AMNCH Hospital

Dublin, 24, Ireland

Location

Mater Misericordiae Hospital

Dublin, 7, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Institute of Oncology, Davidoff Center

Petah Tikva, 49100, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica

Chieti Scalo, 66013, Italy

Location

Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona

Cremona, 26100, Italy

Location

IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro

Genova, 16132, Italy

Location

Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

Milan, 20133, Italy

Location

Divisione di Oncologia, AORN Antonio Cardarelli

Napoli, 80131, Italy

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Torre Medica Cristobal Colon

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

"Vesalius" Sp. z o.o.

Krakow, 31-108, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A

Lodz, 90-549, Poland

Location

Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow

Lodz, 90-549, Poland

Location

Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

Poznan, 60-569, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Klinika Onkologii, Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny

Wroclaw, 50-556, Poland

Location

Univerzitna nemocnica Bratislava

Bratislava, 833 05, Slovakia

Location

Narodny Onkologicky ustav

Bratislava, 833 10, Slovakia

Location

Univerzitna nemocnica Martin

Martin, 036 59, Slovakia

Location

Fakultna nemocnica s poliklinikou

Žilina, 012 07, Slovakia

Location

Department of Internal Medicine, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggido, Korea, Republic of, 10408, South Korea

Location

Samsung Medical Center

Seoul, Korea, Republic of, 06351, South Korea

Location

Asan Medical Center

Seoul, Seoul Korea, Republic of, 05505, South Korea

Location

Korea University Anam Hospital

Seoul, Seoul Teugbyeolsi, 02841, South Korea

Location

Institut Catala D'Oncologia (I.C.O)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

A Coruña, 15006, Spain

Location

Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinico de Barcelona

Barcelona, 08036, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Verksamheten urologi, SU/Sahlgrenska

Gothenburg, 413 45, Sweden

Location

Onkologiska kliniken, Universitetssjukhuset

Lund, 221 85, Sweden

Location

Norrlands universitetssjukhus, Urologiska kliniken

Umeå, 901 85, Sweden

Location

Akademiska sjukhuset

Uppsala, 751 85, Sweden

Location

Urologkliniken Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

Centrallasarettet, Onkologkliniken

Västerås, 721 89, Sweden

Location

Onkologisches Institut, Inselspital Bern

Bern, 3010, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YH, United Kingdom

Location

Ross Hall Hospital

Glasgow, G52 3NQ, United Kingdom

Location

Post Graduate Medical School, University of Surrey

Guildford, GU2 7WG, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

St. Mary's Hospital, Imperial College, Health care NHS Trust

London, W2 1NY, United Kingdom

Location

Medical Oncology, Patterson institute for Cancer Research

Manchester, M20 4BX, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 36216827 DERIVED

• 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.

  PMID: 33028084 DERIVED

• 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.

  PMID: 32582758 DERIVED

• 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.

  PMID: 30412222 DERIVED

• 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.

  PMID: 29773662 DERIVED

• 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.

  PMID: 29374054 DERIVED

• 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.

  PMID: 28967554 DERIVED

• 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.

  PMID: 27718781 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1800718

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: August 1, 2007
• Primary Completion: April 7, 2016
• Study Completion: September 7, 2017
• Last Updated: September 21, 2018
• Results First Posted: August 18, 2017

Record last verified: 2018-08

Locations

AU (1); ME (1); DK (1); CO (1); GR (2); MY (1); CZ (6); SL (4); CH (2); DE (16); TW (2); IT (6); CN (13); PL (7); FR (11); KR (5); IE (4); GB (6); US (12); IL (2); ES (6); SE (6)