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ACTIVE NOT RECRUITING
NCT03869892
PHASE3

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

Sponsor: Institut de Recherches Internationales Servier

View on ClinicalTrials.gov

Summary

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

Official title: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

856

Start Date

2019-03-21

Completion Date

2026-12-31

Last Updated

2025-12-22

Healthy Volunteers

No

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.

Locations (190)

Centro de Oncología e Investigación de Buenos Aires COIBA

Berazategui, Argentina

Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

Buenos Aires, Argentina

Fundación Favaloro Oncology Unit

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

Buenos Aires, Argentina

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

La Rioja, Argentina

Fundación COIR Centro Oncológico de Interación Regional

Mendoza, Argentina

Centro Médico San Roque

San Miguel de Tucumán, Argentina

Instituto de Oncología de Rosario

Santa Fe, Argentina

ISIS Centro especializado

Santa Fe, Argentina

Blacktown Hospital Cancer and Haematology Centre

Blacktown, Australia

Frankston Private Peninsula and Southeast Oncology Group

Frankston, Australia

Lake Macquarie Private Hospital

Gateshead, Australia

St George Hospital St George Hospital Cancer Care Centre

Kogarah, Australia

Adventist HealthCare Integrated Cancer Centre

Wahroonga, Australia

Southern Medical Day Care Centre

Wollongong, Australia

Med. Universität Graz Klinische Abteilung für Onkologie

Graz, Austria

Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V

Innsbruck, Austria

Ordensklinikum Linz Barmherzige Schwestern Interne I

Linz, Austria

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

Salzburg, Austria

Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I

Sankt Pölten, Austria

Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

Vienna, Austria

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

Barretos, Brazil

Cenantron - Clinica

Belo Horizonte, Brazil

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

Brasília, Brazil

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

Ijuí, Brazil

Hospital Mae de Deus Oncologia

Porto Alegre, Brazil

Hospital São Rafael Centro Intergrado de Pesquisa

Salvador, Brazil

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

Santo André, Brazil

Hospital de Base Centro Integrado de Pesquisa

São José do Rio Preto, Brazil

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

São Paulo, Brazil

Hospital A C Camargo Unidade de Pesquisa Clinica

São Paulo, Brazil

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

Burgas, Bulgaria

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

Gabrovo, Bulgaria

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

Plovdiv, Bulgaria

"Medical Center Nadezhda Clinical" EOOD Medical Oncology Department

Sofia, Bulgaria

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

Sofia, Bulgaria

MHAT Serdika EOOD Department of Medical Oncology

Sofia, Bulgaria

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

Sofia, Bulgaria

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

Varna, Bulgaria

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

Vratsa, Bulgaria

Masarykuv onkologicky ustav Klinika komplexni onkologicke pece

Brno, Czechia

Fakultni nemocnice Ostrava Klinika onkologicka

Ostrava, Czechia

Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK

Prague, Czechia

Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN

Prague, Czechia

Fakultni nemocnice Olomouc Onkologicka klinika

Prague, Czechia

Aalborg Universitetshospital, Syd Onkologisk Afdelin

Aalborg, Denmark

Rigshospitalet Onkologisk Klinik

Copenhagen, Denmark

Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling

Herning, Denmark

Odense Universitetshospital Onkologisk Afdeling R

Odense, Denmark

East Tallinn Central Hospital Center of Oncology

Tallinn, Estonia

North Estonia Medical Centre Foundation Oncology and Haematology clinic

Tallinn, Estonia

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

Tartu, Estonia

Institut Sainte Catherine

Avignon, France

CHU Jean Minjoz Service d'oncologie médicale

Besançon, France

CHU Morvan Institut de Cancérologie et d'Hématologie

Brest, France

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

Lyon, France

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

Montbéliard, France

Centre Antoine Lacassagne Dpt d'Oncologie Médicale

Nice, France

Hôpital Saint-Antoine Service d'Oncologie Médicale

Paris, France

Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

Paris, France

Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive

Pessac, France

CHU Toulouse Rangueil Oncologie médicale digestive

Toulouse, France

Onkologische Schwerpunktpraxis Kurfuerstendamm

Berlin, Germany

Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

Lübeck, Germany

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

München, Germany

Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

Budapest, Hungary

Semmelweis University Radiology and Oncotherapy Clinic

Budapest, Hungary

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

Budapest, Hungary

Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia

Budapest, Hungary

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

Budapest, Hungary

Uzsoki Utcai Korhaz Onkoradiologiai Osztaly

Budapest, Hungary

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

Debrecen, Hungary

Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

Győr, Hungary

Bekes Megyei Kozponti Korhaz

Gyula, Hungary

Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

Kecskemét, Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly

Nyíregyháza, Hungary

Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet

Pécs, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

Szeged, Hungary

JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

Szolnok, Hungary

Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

Szombathely, Hungary

Zala Megyei Korhaz Onkologiai osztaly

Zalaegerszeg, Hungary

Bon Secours Hospital

Cork, Ireland

Cork University Hospital Department of Medical Oncology

Cork, Ireland

The Adelaide and Meath Hospital

Dublin, Ireland

Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica

Cagliari, Italy

Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA

Cremona, Italy

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

Naples, Italy

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

Padova, Italy

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

Pisa, Italy

Ospedale San Carlo U.O. Oncologia Medica

Potenza, Italy

Arcispedale Santa Maria Nuova Unità di Oncologia

Reggio Emilia, Italy

Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

Roma, Italy

Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

Rozzano (MI), Italy

IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

San Giovanni Rotondo, Italy

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

Vicenza, Italy

P. Stradins Clinical University Hospital

Riga, Latvia

Riga East Univerity Hospital Oncology Centre of Latvia

Riga, Latvia

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

Kaunas, Lithuania

Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute

Kaunas, Lithuania

Klaipeda University hospital

Klaipėda, Lithuania

National Cancer Institute

Vilnius, Lithuania

Rijnstate Oncologie

Arnhem, Netherlands

Albert Schweitzer Ziekenhuis Interne Geneeskunde

Dordrecht, Netherlands

Catharina Ziekenhuis Interne Gesneeskunde/Oncologie

Eindhoven, Netherlands

Ikazia Ziekenhuis Oncologie

Rotterdam, Netherlands

ETZ Elisabeth Interne Geneeskunde

Tilburg, Netherlands

Bernhoven Interne Geneeskunde

Uden, Netherlands

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

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

Gdansk, Poland

Przychodnia Lekarska "KOMED"

Konin, Poland

M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow

Lodz, Poland

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

Olsztyn, Poland

Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

Opole, Poland

Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

Poznan, Poland

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

Tomaszów Mazowiecki, Poland

Hospital Garcia de Orta Serviço de Oncologia Médica

Almada, Portugal

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

Coimbra, Portugal

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

Lisbon, Portugal

Hospital Beatriz Ângelo Serviço de oncologia medic

Loures, Portugal

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

Porto, Portugal

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

Bucharest, Romania

Spitalul Clinic "Coltea" Sectia Oncologie Medicala

Bucharest, Romania

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

Cluj-Napoca, Romania

Centrul de Oncologie Sf Nectarie Oncology Department

Craiova, Romania

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

Craiova, Romania

Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

Iași, Romania

Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala

Sibiu, Romania

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

Timișoara, Romania

Arkhangelsk Clinical Oncology Dispensary chemotherapy department

Arkhangelsk, Russia

Clinical Oncology Dispensary No.1 Chemotherapy Department

Krasnodar, Russia

Kursk Regional Clinical Oncology Dispensary Oncology Department

Kursk, Russia

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

Moscow, Russia

University Headache Clinic Outpatient oncology clinic

Moscow, Russia

Moscow City Oncology Hospital # 62 chemotherapy department

Moscow, Russia

Omsk Clinical Oncologic Dispensary Chemotherapy

Omsk, Russia

Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department

Pyatigorsk, Russia

Rostov Research Institute of Oncology Chemotherapy department

Rostov-on-Don, Russia

Regional Clinical Oncology Dispensary

Ryazan, Russia

Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

Saint Petersburg, Russia

National Medical Research Center of Oncology N.N. Petrova

Saint Petersburg, Russia

Saint Petersburg City Oncology Clilnic

Saint Petersburg, Russia

Multidisciplinary clinic "Reaviz"

Samara, Russia

Oncology Dispensary No.2

Sochi, Russia

State Research Institution of Oncology of Tomsk Chemotherapy

Tomsk, Russia

SBIH of YR "Clinical oncology hospital" chemotherapy department

Yaroslavl, Russia

Narodny onkologicky ustav Oddelenie klinickej onkologie

Bratislava, Slovakia

Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

Košice, Slovakia

Hospital General Universitario Alicante Servicio de Oncología

Alicante, Spain

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

Badalona, Spain

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

Barcelona, Spain

Hospital de la Santa Creu I Sant Pau Oncología Medica

Barcelona, Spain

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

Córdoba, Spain

INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica

L'Hospitalet de Llobregat, Spain

Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica

Madrid, Spain

Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica

Madrid, Spain

H. Clínico San Carlos Servicio de Oncología Médica

Madrid, Spain

HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica

Madrid, Spain

H. Universitario La Paz Oncología Médica

Madrid, Spain

Hospital Universitario Marqués de Valdecilla Oncología médica

Santander, Spain

H.Virgen Del Rocio

Seville, Spain

Hospital Quirónsalud Valencia Servicio de Oncología Médica

Valencia, Spain

Hospital Universitario Miguel Servet Servicio de Oncología

Zaragoza, Spain

Falu Lasarett Onkologmottagningen

Falun, Sweden

Lanssjukhuset Ryhov Onkologiska kliniken

Jönköping, Sweden

Universitetssjukhuset Orebro

Örebro, Sweden

Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09

Solna, Sweden

Norrlands Universitetssjukhus Cancercentrum Umea

Umeå, Sweden

Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

Cherkasy, Ukraine

Dnipro Regional Oncology Dispensary

Dnipro, Ukraine

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

Dnipro, Ukraine

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

Kharkiv, Ukraine

National Institute of Cancer Abdominal Oncology Department

Kyiv, Ukraine

Kyiv City Clinical Oncology Centre Chemotherapy Department #2

Kyiv, Ukraine

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

Kyiv, Ukraine

Lviv Regional Oncology Center Chemotherapy department

Lviv, Ukraine

Odesa Regional Oncology Dispensary Day patient Department

Odesa, Ukraine

Podillia Regional Oncology Centre Chemotherapy Department

Vinnytsia, Ukraine

Regional Clinical Oncological Dispensary Department of Oncology

Zaporizhzhya, Ukraine

Aberdeen Royal Infirmary Oncology Department

Aberdeen, United Kingdom

University Hospitals Bristol Bristol Haematology & Oncology Centre

Bristol, United Kingdom

St James's University Hospital

Leeds, United Kingdom

Leicester Royal Infirmary The HOPE Clinical Trials Unit

Leicester, United Kingdom

Royal Marsden Hospital Department of Medicine

London, United Kingdom

Hammersmith Hospital Gary Weston Centre

London, United Kingdom

Sarah Cannon Research Institute UK Clinical Trials

London, United Kingdom

Imperial Healthcare NHS Trust Charing Cross Hospital

London, United Kingdom

Christie Hospital NHS Foundation Trust GI & Endocrine

Manchester, United Kingdom

Glan Clwyd Hospital North Wales Cancer Treatment Centre

Rhyl, United Kingdom

Royal Marsden Hospital Department of Medicine

Sutton, United Kingdom