Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

856

Participants

Timeline

Start Date

March 21, 2019

Primary Completion Date

June 29, 2021

Study Completion Date

December 31, 2025

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

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.

DRUG

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (190)

90

Bon Secours Hospital, Cork

1002

P. Stradins Clinical University Hospital, Riga

1062

Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly, Budapest

1079

Riga East Univerity Hospital Oncology Centre of Latvia, Riga

1083

Semmelweis University Radiology and Oncotherapy Clinic, Budapest

1090

Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie, Vienna

1097

Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely, Budapest

1115

Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia, Budapest

1122

"Orszagos Onkologiai Intezet B Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.", Budapest

1145

Uzsoki Utcai Korhaz Onkoradiologiai Osztaly, Budapest

1264

Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit, Buenos Aires

1330

"Medical Center Nadezhda Clinical EOOD Medical Oncology Department", Sofia

1431

"UMHAT Sv. Ivan Rilski EAD Clinic of clinical hematology, Dpt. of medical oncology", Sofia

1632

MHAT Serdika EOOD Department of Medical Oncology, Sofia

1756

Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care, Sofia

2076

Adventist HealthCare Integrated Cancer Centre, Wahroonga

2100

Rigshospitalet Onkologisk Klinik, Copenhagen

2148

Blacktown Hospital Cancer and Haematology Centre, Blacktown

2217

St George Hospital St George Hospital Cancer Care Centre, Kogarah

2290

Lake Macquarie Private Hospital, Gateshead

2500

Southern Medical Day Care Centre, Wollongong

3000

"Complex Ongology Center - Vratsa EOOD Department of Medical oncology", Vratsa

3100

Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I, Sankt Pölten

3199

Frankston Private Peninsula and Southeast Oncology Group, Frankston

4004

"Complex oncology center - Plovdiv EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology", Plovdiv

4010

Ordensklinikum Linz Barmherzige Schwestern Interne I, Linz

4032

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet, Debrecen

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly, Nyíregyháza

5000

Odense Universitetshospital Onkologisk Afdeling R, Odense

5004

JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum, Szolnok

5020

Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK), Salzburg

5300

"Multiprofile hosp. for active treatmen Dr. Tota Venkova AD Department of medical oncology", Gabrovo

5500

Fundación COIR Centro Oncológico de Interación Regional, Mendoza

6000

Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont, Kecskemét

6020

Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V, Innsbruck

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika, Szeged

7400

Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling, Herning

7624

Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet, Pécs

8000

"Complex oncology center - Burgas EOOD Department of medical oncology", Burgas

8036

Med. Universität Graz Klinische Abteilung für Onkologie, Graz

8900

Zala Megyei Korhaz Onkologiai osztaly, Zalaegerszeg

9000

Aalborg Universitetshospital, Syd Onkologisk Afdelin, Aalborg

9003

"SHAT of oncology diseases Dr. Marko Antonov Markov EOOD Department of medical oncology and palliative therapy", Varna

9024

Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly, Győr

9700

Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly, Szombathely

10707

Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin

11312

East Tallinn Central Hospital Center of Oncology, Tallinn

13419

North Estonia Medical Centre Foundation Oncology and Haematology clinic, Tallinn

14004

Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica, Córdoba

18009

Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre, Cherkasy

20089

Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia, Rozzano (MI)

21029

Podillia Regional Oncology Centre Chemotherapy Department, Vinnytsia

23562

Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei, Lübeck

25030

CHU Jean Minjoz Service d'oncologie médicale, Besançon

25209

Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale, Montbéliard

26100

Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA, Cremona

28007

Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica, Madrid

28034

Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica, Madrid

28040

H. Clínico San Carlos Servicio de Oncología Médica, Madrid

28041

HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica, Madrid

28046

H. Universitario La Paz Oncología Médica, Madrid

29200

CHU Morvan Institut de Cancérologie et d'Hématologie, Brest

31059

CHU Toulouse Rangueil Oncologie médicale digestive, Toulouse

33604

Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive, Pessac

35128

Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1, Padua

36100

Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA, Vicenza

39008

Hospital Universitario Marqués de Valdecilla Oncología médica, Santander

41013

H.Virgen Del Rocio, Seville

42123

Arcispedale Santa Maria Nuova Unità di Oncologia, Reggio Emilia

45434

Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos, Kaunas

46010

Hospital Quirónsalud Valencia Servicio de Oncología Médica, Valencia

49055

Dnipro Regional Oncology Dispensary, Dnipro

49102

"MI Dnipropetrovsk City Multi-field Clinical Hospital #4 Department of Oncology", Dnipro

50009

Hospital Universitario Miguel Servet Servicio de Oncología, Zaragoza

51014

Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy, Tartu

56126

A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2, Pisa

57000

Bekes Megyei Kozponti Korhaz, Gyula

61024

Institute of Medical Radiology of S.P. Grygoryev of AMS UKR, Kharkiv

65010

Odesa Regional Oncology Dispensary Day patient Department, Odesa

69000

Regional Clinical Oncological Dispensary Department of Oncology, Zaporizhzhya

69008

Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale, Lyon

71013

IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia, San Giovanni Rotondo

75012

Hôpital Saint-Antoine Service d'Oncologie Médicale, Paris

75015

Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive, Paris

77900

Fakultni nemocnice Olomouc Onkologicka klinika, Prague

79031

Lviv Regional Oncology Center Chemotherapy department, Lviv

80131

"Istituto Nazionale Tumori I.R.C.C.S Fondazione G. Pascale Struttura Complessa di Oncologia Medica Addominale", Napoli

81377

Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III, München

84918

Institut Sainte Catherine, Avignon

85100

Ospedale San Carlo U.O. Oncologia Medica, Potenza

92288

Klaipeda University hospital, Klaipėda

115478

Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy, Moscow

Scientific Centre for Specialized Medical Care (oncological) Chemotherapy, Saint Petersburg

121467

University Headache Clinic Outpatient oncology clinic, Moscow

143423

Moscow City Oncology Hospital # 62 chemotherapy department, Moscow

150054

"SBIH of YR Clinical oncology hospital chemotherapy department", Yaroslavl

163045

Arkhangelsk Clinical Oncology Dispensary chemotherapy department, Arkhangelsk

197758

National Medical Research Center of Oncology N.N. Petrova, Saint Petersburg

198255

Saint Petersburg City Oncology Clilnic, Saint Petersburg

200347

Centrul de Oncologie Sf Nectarie Oncology Department, Craiova

200385

S.C Oncolab S.R.L Sectia Oncologie Medicala, Craiova

300239

S.C ONCOMED S.R.L Departament Oncologie Medicala, Timișoara

305524

Kursk Regional Clinical Oncology Dispensary Oncology Department, Kursk

344037

Rostov Research Institute of Oncology Chemotherapy department, Rostov-on-Don

350040

Clinical Oncology Dispensary No.1 Chemotherapy Department, Krasnodar

354057

Oncology Dispensary No.2, Sochi

357502

Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department, Pyatigorsk

390011

Regional Clinical Oncology Dispensary, Ryazan

400015

"Institutul Oncologic Prof. Dr. I. Chiricuta Cluj Napoca Oncologie Medicala", Cluj-Napoca

443011

"Multidisciplinary clinic Reaviz", Samara

550245

Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala, Sibiu

634024

State Research Institution of Oncology of Tomsk Chemotherapy, Tomsk

644046

Omsk Clinical Oncologic Dispensary Chemotherapy, Omsk

700483

Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala, Iași

B1884BBF

Centro de Oncología e Investigación de Buenos Aires COIBA, Berazategui

C1093AAS

Fundación Favaloro Oncology Unit, Buenos Aires

C1426ANZ

Instituto Alexander Fleming, Buenos Aires

C1431FWO

Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales, Buenos Aires

F5300COE

Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer, La Rioja

T4000IAK

Centro Médico San Roque, San Miguel de Tucumán

S2000KZE

Instituto de Oncología de Rosario, Santa Fe

S3000FFU

ISIS Centro especializado, Santa Fe

14784-400

Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica, Barretos

30150-320

Cenantron - Clinica, Belo Horizonte

70200-730

Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa, Brasília

98700-000

Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica, Ijuí

90880-480

Hospital Mae de Deus Oncologia, Porto Alegre

41253-191

Hospital São Rafael Centro Intergrado de Pesquisa, Salvador

09060-870

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa, Santo André

15090-000

Hospital de Base Centro Integrado de Pesquisa, São José do Rio Preto

01246-000

ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa, São Paulo

01509-900

Hospital A C Camargo Unidade de Pesquisa Clinica, São Paulo

656 53

Masarykuv onkologicky ustav Klinika komplexni onkologicke pece, Brno

Unknown

Fakultni nemocnice Ostrava Klinika onkologicka, Ostrava

128 08

Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK, Prague

140 59

Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN, Prague

06189

Centre Antoine Lacassagne Dpt d'Oncologie Médicale, Nice

T12 DC4A

Cork University Hospital Department of Medical Oncology, Cork

D24 NROA

The Adelaide and Meath Hospital, Dublin

09100

Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica, Cagliari

00128

Policlinico Universitario Campus Biomedico UOC di Oncologia Medica, Roma

LT-50161

Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute, Kaunas

LT-08660

National Cancer Institute, Vilnius

6815 AD

Rijnstate Oncologie, Arnhem

3318 AT

Albert Schweitzer Ziekenhuis Interne Geneeskunde, Dordrecht

5623 EJ

Catharina Ziekenhuis Interne Gesneeskunde/Oncologie, Eindhoven

3083 AN

Ikazia Ziekenhuis Oncologie, Rotterdam

5022 GC

ETZ Elisabeth Interne Geneeskunde, Tilburg

5406 PT

Bernhoven Interne Geneeskunde, Uden

15-027

Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej, Bialystok

80-952

Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk

62-500

"Przychodnia Lekarska KOMED", Konin

93-513

M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow, Lodz

10-228

SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii, Olsztyn

45-061

Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej, Opole

61-866

Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii, Poznan

97-200

NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi, Tomaszów Mazowiecki

2805-267

Hospital Garcia de Orta Serviço de Oncologia Médica, Almada

3000-075

Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID), Coimbra

1649-035

Centro Hospitalar Lisboa Norte, Hospital de Santa Maria Serviço de Oncologia Médica, Lisbon

2674-514

Hospital Beatriz Ângelo Serviço de oncologia medic, Loures

4200-072

Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept., Porto

022328

"Institutul Oncologic Prof Alexandru Trestioreanu Busuresti Sectia Oncologie Medicala I", Bucharest

030171

"Spitalul Clinic Coltea Sectia Oncologie Medicala", Bucharest

833 10

Narodny onkologicky ustav Oddelenie klinickej onkologie, Bratislava

04191

Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie, Košice

03010

Hospital General Universitario Alicante Servicio de Oncología, Alicante

08916

Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica, Badalona

08035

H. Valle de Hebrón Servicio de Oncología - (VHIR), Barcelona

08041

Hospital de la Santa Creu I Sant Pau Oncología Medica, Barcelona

08908

INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica, L'Hospitalet de Llobregat

791 82

Falu Lasarett Onkologmottagningen, Falun

551 85

Lanssjukhuset Ryhov Onkologiska kliniken, Jönköping

701 85

Universitetssjukhuset Orebro, Örebro

171 64

Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09, Solna

901 85

Norrlands Universitetssjukhus Cancercentrum Umea, Umeå

03022

National Institute of Cancer Abdominal Oncology Department, Kyiv

03115

Kyiv City Clinical Oncology Centre Chemotherapy Department #2, Kyiv

04107

"Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital, proctology department", Kyiv

AB25 2ZN

Aberdeen Royal Infirmary Oncology Department, Aberdeen

BS2 8ED

University Hospitals Bristol Bristol Haematology & Oncology Centre, Bristol

LS9 7TF

St James's University Hospital, Leeds

LE1 5WW

Leicester Royal Infirmary The HOPE Clinical Trials Unit, Leicester

SW3 6JJ

Royal Marsden Hospital Department of Medicine, London

W12 0HS

Hammersmith Hospital Gary Weston Centre, London

W1G 6AD

Sarah Cannon Research Institute UK Clinical Trials, London

W6 8RF

Imperial Healthcare NHS Trust Charing Cross Hospital, London

M20 4BX

Christie Hospital NHS Foundation Trust GI & Endocrine, Manchester

LL18 5UJ

Glan Clwyd Hospital North Wales Cancer Treatment Centre, Rhyl

SM2 5PT

Royal Marsden Hospital Department of Medicine, Sutton

All Listed Sponsors
collaborator

ADIR, a Servier Group company

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER