856
Participants
Start Date
March 21, 2019
Primary Completion Date
June 29, 2021
Study Completion Date
December 31, 2025
Trifluridine/tipiracil hydrochloride (S95005)
Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.
Capecitabine
Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.
Bevacizumab experimental
Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.
Bevacizumab control
Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.
Bon Secours Hospital, Cork
P. Stradins Clinical University Hospital, Riga
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly, Budapest
Riga East Univerity Hospital Oncology Centre of Latvia, Riga
Semmelweis University Radiology and Oncotherapy Clinic, Budapest
Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie, Vienna
Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely, Budapest
Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia, Budapest
"Orszagos Onkologiai Intezet B Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.", Budapest
Uzsoki Utcai Korhaz Onkoradiologiai Osztaly, Budapest
Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit, Buenos Aires
"Medical Center Nadezhda Clinical EOOD Medical Oncology Department", Sofia
"UMHAT Sv. Ivan Rilski EAD Clinic of clinical hematology, Dpt. of medical oncology", Sofia
MHAT Serdika EOOD Department of Medical Oncology, Sofia
Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care, Sofia
Adventist HealthCare Integrated Cancer Centre, Wahroonga
Rigshospitalet Onkologisk Klinik, Copenhagen
Blacktown Hospital Cancer and Haematology Centre, Blacktown
St George Hospital St George Hospital Cancer Care Centre, Kogarah
Lake Macquarie Private Hospital, Gateshead
Southern Medical Day Care Centre, Wollongong
"Complex Ongology Center - Vratsa EOOD Department of Medical oncology", Vratsa
Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I, Sankt Pölten
Frankston Private Peninsula and Southeast Oncology Group, Frankston
"Complex oncology center - Plovdiv EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology", Plovdiv
Ordensklinikum Linz Barmherzige Schwestern Interne I, Linz
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet, Debrecen
Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly, Nyíregyháza
Odense Universitetshospital Onkologisk Afdeling R, Odense
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum, Szolnok
Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK), Salzburg
"Multiprofile hosp. for active treatmen Dr. Tota Venkova AD Department of medical oncology", Gabrovo
Fundación COIR Centro Oncológico de Interación Regional, Mendoza
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont, Kecskemét
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V, Innsbruck
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika, Szeged
Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling, Herning
Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet, Pécs
"Complex oncology center - Burgas EOOD Department of medical oncology", Burgas
Med. Universität Graz Klinische Abteilung für Onkologie, Graz
Zala Megyei Korhaz Onkologiai osztaly, Zalaegerszeg
Aalborg Universitetshospital, Syd Onkologisk Afdelin, Aalborg
"SHAT of oncology diseases Dr. Marko Antonov Markov EOOD Department of medical oncology and palliative therapy", Varna
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly, Győr
Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly, Szombathely
Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin
East Tallinn Central Hospital Center of Oncology, Tallinn
North Estonia Medical Centre Foundation Oncology and Haematology clinic, Tallinn
Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica, Córdoba
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre, Cherkasy
Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia, Rozzano (MI)
Podillia Regional Oncology Centre Chemotherapy Department, Vinnytsia
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei, Lübeck
CHU Jean Minjoz Service d'oncologie médicale, Besançon
Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale, Montbéliard
Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA, Cremona
Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica, Madrid
Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica, Madrid
H. Clínico San Carlos Servicio de Oncología Médica, Madrid
HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica, Madrid
H. Universitario La Paz Oncología Médica, Madrid
CHU Morvan Institut de Cancérologie et d'Hématologie, Brest
CHU Toulouse Rangueil Oncologie médicale digestive, Toulouse
Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive, Pessac
Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1, Padua
Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA, Vicenza
Hospital Universitario Marqués de Valdecilla Oncología médica, Santander
H.Virgen Del Rocio, Seville
Arcispedale Santa Maria Nuova Unità di Oncologia, Reggio Emilia
Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos, Kaunas
Hospital Quirónsalud Valencia Servicio de Oncología Médica, Valencia
Dnipro Regional Oncology Dispensary, Dnipro
"MI Dnipropetrovsk City Multi-field Clinical Hospital #4 Department of Oncology", Dnipro
Hospital Universitario Miguel Servet Servicio de Oncología, Zaragoza
Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy, Tartu
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2, Pisa
Bekes Megyei Kozponti Korhaz, Gyula
Institute of Medical Radiology of S.P. Grygoryev of AMS UKR, Kharkiv
Odesa Regional Oncology Dispensary Day patient Department, Odesa
Regional Clinical Oncological Dispensary Department of Oncology, Zaporizhzhya
Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale, Lyon
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia, San Giovanni Rotondo
Hôpital Saint-Antoine Service d'Oncologie Médicale, Paris
Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive, Paris
Fakultni nemocnice Olomouc Onkologicka klinika, Prague
Lviv Regional Oncology Center Chemotherapy department, Lviv
"Istituto Nazionale Tumori I.R.C.C.S Fondazione G. Pascale Struttura Complessa di Oncologia Medica Addominale", Napoli
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III, München
Institut Sainte Catherine, Avignon
Ospedale San Carlo U.O. Oncologia Medica, Potenza
Klaipeda University hospital, Klaipėda
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy, Moscow
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy, Saint Petersburg
University Headache Clinic Outpatient oncology clinic, Moscow
Moscow City Oncology Hospital # 62 chemotherapy department, Moscow
"SBIH of YR Clinical oncology hospital chemotherapy department", Yaroslavl
Arkhangelsk Clinical Oncology Dispensary chemotherapy department, Arkhangelsk
National Medical Research Center of Oncology N.N. Petrova, Saint Petersburg
Saint Petersburg City Oncology Clilnic, Saint Petersburg
Centrul de Oncologie Sf Nectarie Oncology Department, Craiova
S.C Oncolab S.R.L Sectia Oncologie Medicala, Craiova
S.C ONCOMED S.R.L Departament Oncologie Medicala, Timișoara
Kursk Regional Clinical Oncology Dispensary Oncology Department, Kursk
Rostov Research Institute of Oncology Chemotherapy department, Rostov-on-Don
Clinical Oncology Dispensary No.1 Chemotherapy Department, Krasnodar
Oncology Dispensary No.2, Sochi
Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department, Pyatigorsk
Regional Clinical Oncology Dispensary, Ryazan
"Institutul Oncologic Prof. Dr. I. Chiricuta Cluj Napoca Oncologie Medicala", Cluj-Napoca
"Multidisciplinary clinic Reaviz", Samara
Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala, Sibiu
State Research Institution of Oncology of Tomsk Chemotherapy, Tomsk
Omsk Clinical Oncologic Dispensary Chemotherapy, Omsk
Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala, Iași
Centro de Oncología e Investigación de Buenos Aires COIBA, Berazategui
Fundación Favaloro Oncology Unit, Buenos Aires
Instituto Alexander Fleming, Buenos Aires
Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales, Buenos Aires
Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer, La Rioja
Centro Médico San Roque, San Miguel de Tucumán
Instituto de Oncología de Rosario, Santa Fe
ISIS Centro especializado, Santa Fe
Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica, Barretos
Cenantron - Clinica, Belo Horizonte
Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa, Brasília
Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica, Ijuí
Hospital Mae de Deus Oncologia, Porto Alegre
Hospital São Rafael Centro Intergrado de Pesquisa, Salvador
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa, Santo André
Hospital de Base Centro Integrado de Pesquisa, São José do Rio Preto
ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa, São Paulo
Hospital A C Camargo Unidade de Pesquisa Clinica, São Paulo
Masarykuv onkologicky ustav Klinika komplexni onkologicke pece, Brno
Fakultni nemocnice Ostrava Klinika onkologicka, Ostrava
Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK, Prague
Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN, Prague
Centre Antoine Lacassagne Dpt d'Oncologie Médicale, Nice
Cork University Hospital Department of Medical Oncology, Cork
The Adelaide and Meath Hospital, Dublin
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica, Cagliari
Policlinico Universitario Campus Biomedico UOC di Oncologia Medica, Roma
Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute, Kaunas
National Cancer Institute, Vilnius
Rijnstate Oncologie, Arnhem
Albert Schweitzer Ziekenhuis Interne Geneeskunde, Dordrecht
Catharina Ziekenhuis Interne Gesneeskunde/Oncologie, Eindhoven
Ikazia Ziekenhuis Oncologie, Rotterdam
ETZ Elisabeth Interne Geneeskunde, Tilburg
Bernhoven Interne Geneeskunde, Uden
Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej, Bialystok
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk
"Przychodnia Lekarska KOMED", Konin
M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow, Lodz
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii, Olsztyn
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej, Opole
Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii, Poznan
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi, Tomaszów Mazowiecki
Hospital Garcia de Orta Serviço de Oncologia Médica, Almada
Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID), Coimbra
Centro Hospitalar Lisboa Norte, Hospital de Santa Maria Serviço de Oncologia Médica, Lisbon
Hospital Beatriz Ângelo Serviço de oncologia medic, Loures
Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept., Porto
"Institutul Oncologic Prof Alexandru Trestioreanu Busuresti Sectia Oncologie Medicala I", Bucharest
"Spitalul Clinic Coltea Sectia Oncologie Medicala", Bucharest
Narodny onkologicky ustav Oddelenie klinickej onkologie, Bratislava
Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie, Košice
Hospital General Universitario Alicante Servicio de Oncología, Alicante
Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica, Badalona
H. Valle de Hebrón Servicio de Oncología - (VHIR), Barcelona
Hospital de la Santa Creu I Sant Pau Oncología Medica, Barcelona
INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica, L'Hospitalet de Llobregat
Falu Lasarett Onkologmottagningen, Falun
Lanssjukhuset Ryhov Onkologiska kliniken, Jönköping
Universitetssjukhuset Orebro, Örebro
Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09, Solna
Norrlands Universitetssjukhus Cancercentrum Umea, Umeå
National Institute of Cancer Abdominal Oncology Department, Kyiv
Kyiv City Clinical Oncology Centre Chemotherapy Department #2, Kyiv
"Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital, proctology department", Kyiv
Aberdeen Royal Infirmary Oncology Department, Aberdeen
University Hospitals Bristol Bristol Haematology & Oncology Centre, Bristol
St James's University Hospital, Leeds
Leicester Royal Infirmary The HOPE Clinical Trials Unit, Leicester
Royal Marsden Hospital Department of Medicine, London
Hammersmith Hospital Gary Weston Centre, London
Sarah Cannon Research Institute UK Clinical Trials, London
Imperial Healthcare NHS Trust Charing Cross Hospital, London
Christie Hospital NHS Foundation Trust GI & Endocrine, Manchester
Glan Clwyd Hospital North Wales Cancer Treatment Centre, Rhyl
Royal Marsden Hospital Department of Medicine, Sutton
ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER