AzTrials
AzTrials

Metastatic Colorectal CancerPhase 3SOLSTICENCT03869892

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

A Phase 3 study testing Trifluridine/tipiracil hydrochloride (S95005), Capecitabine and Bevacizumab experimental in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 190 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Trifluridine/tipiracil hydrochloride (S95005), Capecitabine and Bevacizumab experimental
Could I receive a placebo?
No, everyone receives an active treatment
How many people
856 participants
Where
190 sitesin 25 countries
Study dates
21 Mar 2019to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
  • RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
  • Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
  • Patient is not a candidate for curative resection of metastatic lesions.
  • No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  • Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

Who cannot join

  • Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
  • Participation in another interventional study within 4 weeks prior to the randomisation .
  • Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
  • Symptomatic central nervous system metastases.
  • Major surgery within 4 weeks prior to the randomisation.
  • History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
Show all 9Show fewer
  • Any contraindication present in the SmPC of trifluridine/tipiracil
  • Any contraindication present in the SmPC of bevacizumab
  • Any contraindication present in the SmPC of capecitabine

Trial locations and contacts

190 sites in 25 countries.

190 sites in 25 countries

Russia17 sites

  • Arkhangelsk Clinical Oncology Dispensary chemotherapy department

    Arkhangelsk, 163045

  • Clinical Oncology Dispensary No.1 Chemotherapy Department

    Krasnodar, 350040

  • Kursk Regional Clinical Oncology Dispensary Oncology Department

    Kursk, 305524

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

    Moscow, 115478

  • University Headache Clinic Outpatient oncology clinic

    Moscow, 121467

  • Moscow City Oncology Hospital # 62 chemotherapy department

    Moscow, 143423

  • Omsk Clinical Oncologic Dispensary Chemotherapy

    Omsk, 644046

  • Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department

    Pyatigorsk, 357502

  • Rostov Research Institute of Oncology Chemotherapy department

    Rostov-on-Don, 344037

  • Regional Clinical Oncology Dispensary

    Ryazan, 390011

  • Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

    Saint Petersburg, 115478

  • National Medical Research Center of Oncology N.N. Petrova

    Saint Petersburg, 197758

  • Saint Petersburg City Oncology Clilnic

    Saint Petersburg, 198255

  • Multidisciplinary clinic "Reaviz"

    Samara, 443011

  • Oncology Dispensary No.2

    Sochi, 354057

  • State Research Institution of Oncology of Tomsk Chemotherapy

    Tomsk, 634024

  • SBIH of YR "Clinical oncology hospital" chemotherapy department

    Yaroslavl, 150054

Other trials in Russia

Hungary16 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

    Budapest, 1062

  • Semmelweis University Radiology and Oncotherapy Clinic

    Budapest, 1083

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

    Budapest, 1097

  • Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia

    Budapest, 1115

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

    Budapest, 1122

  • Uzsoki Utcai Korhaz Onkoradiologiai Osztaly

    Budapest, 1145

  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

    Győr, 9024

  • Bekes Megyei Kozponti Korhaz

    Gyula, 57000

  • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

    Kecskemét, 6000

  • Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet

    Pécs, 7624

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

    Szeged, 6720

  • JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

    Szolnok, 5004

  • Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

    Szombathely, 9700

  • Zala Megyei Korhaz Onkologiai osztaly

    Zalaegerszeg, 8900

Other trials in Hungary

Spain15 sites

  • Hospital General Universitario Alicante Servicio de Oncología

    Alicante, 03010

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

    Badalona, 08916

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

    Barcelona, 08035

  • Hospital de la Santa Creu I Sant Pau Oncología Medica

    Barcelona, 08041

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

    Córdoba, 14004

  • INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica

    L'Hospitalet de Llobregat, 08908

  • Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica

    Madrid, 28034

  • H. Clínico San Carlos Servicio de Oncología Médica

    Madrid, 28040

  • HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica

    Madrid, 28041

  • H. Universitario La Paz Oncología Médica

    Madrid, 28046

  • Hospital Universitario Marqués de Valdecilla Oncología médica

    Santander, 39008

  • H.Virgen Del Rocio

    Seville, 41013

  • Hospital Quirónsalud Valencia Servicio de Oncología Médica

    Valencia, 46010

  • Hospital Universitario Miguel Servet Servicio de Oncología

    Zaragoza, 50009

Other trials in Spain

Italy11 sites

  • Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica

    Cagliari, 09100

  • Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA

    Cremona, 26100

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

    Naples, 80131

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

    Padova, 35128

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

    Pisa, 56126

  • Ospedale San Carlo U.O. Oncologia Medica

    Potenza, 85100

  • Arcispedale Santa Maria Nuova Unità di Oncologia

    Reggio Emilia, 42123

  • Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

    Roma, 00128

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

    Rozzano (MI), 20089

  • IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

    San Giovanni Rotondo, 71013

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

    Vicenza, 36100

Other trials in Italy

Ukraine11 sites

  • Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

    Cherkasy, 18009

  • Dnipro Regional Oncology Dispensary

    Dnipro, 49055

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

    Dnipro, 49102

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

    Kharkiv, 61024

  • National Institute of Cancer Abdominal Oncology Department

    Kyiv, 03022

  • Kyiv City Clinical Oncology Centre Chemotherapy Department #2

    Kyiv, 03115

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

    Kyiv, 04107

  • Lviv Regional Oncology Center Chemotherapy department

    Lviv, 79031

  • Odesa Regional Oncology Dispensary Day patient Department

    Odesa, 65010

  • Podillia Regional Oncology Centre Chemotherapy Department

    Vinnytsia, 21029

  • Regional Clinical Oncological Dispensary Department of Oncology

    Zaporizhzhya, 69000

Other trials in Ukraine

United Kingdom11 sites

  • Aberdeen Royal Infirmary Oncology Department

    Aberdeen, AB25 2ZN

  • University Hospitals Bristol Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED

  • St James's University Hospital

    Leeds, LS9 7TF

  • Leicester Royal Infirmary The HOPE Clinical Trials Unit

    Leicester, LE1 5WW

  • Royal Marsden Hospital Department of Medicine

    London, SW3 6JJ

  • Hammersmith Hospital Gary Weston Centre

    London, W12 0HS

  • Sarah Cannon Research Institute UK Clinical Trials

    London, W1G 6AD

  • Imperial Healthcare NHS Trust Charing Cross Hospital

    London, W6 8RF

  • Christie Hospital NHS Foundation Trust GI & Endocrine

    Manchester, M20 4BX

  • Glan Clwyd Hospital North Wales Cancer Treatment Centre

    Rhyl, LL18 5UJ

  • Royal Marsden Hospital Department of Medicine

    Sutton, SM2 5PT

Other trials in United Kingdom

Argentina10 sites

  • Centro de Oncología e Investigación de Buenos Aires COIBA

    Berazategui, B1884BBF

  • Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

    Buenos Aires, 1264

  • Fundación Favaloro Oncology Unit

    Buenos Aires, C1093AAS

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

  • Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

    Buenos Aires, C1431FWO

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

    La Rioja, F5300COE

  • Fundación COIR Centro Oncológico de Interación Regional

    Mendoza, 5500

  • Centro Médico San Roque

    San Miguel de Tucumán, T4000IAK

  • Instituto de Oncología de Rosario

    Santa Fe, S2000KZE

  • ISIS Centro especializado

    Santa Fe, S3000FFU

Other trials in Argentina

Brazil10 sites

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

    Barretos, 14784-400

  • Cenantron - Clinica

    Belo Horizonte, 30150-320

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

    Brasília, 70200-730

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

    Ijuí, 98700-000

  • Hospital Mae de Deus Oncologia

    Porto Alegre, 90880-480

  • Hospital São Rafael Centro Intergrado de Pesquisa

    Salvador, 41253-191

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

    Santo André, 09060-870

  • Hospital de Base Centro Integrado de Pesquisa

    São José do Rio Preto, 15090-000

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

    São Paulo, 01246-000

  • Hospital A C Camargo Unidade de Pesquisa Clinica

    São Paulo, 01509-900

Other trials in Brazil

France10 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • CHU Jean Minjoz Service d'oncologie médicale

    Besançon, 25030

  • CHU Morvan Institut de Cancérologie et d'Hématologie

    Brest, 29200

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

    Lyon, 69008

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

    Montbéliard, 25209

  • Centre Antoine Lacassagne Dpt d'Oncologie Médicale

    Nice, 06189

  • Hôpital Saint-Antoine Service d'Oncologie Médicale

    Paris, 75012

  • Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

    Paris, 75015

  • Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive

    Pessac, 33604

  • CHU Toulouse Rangueil Oncologie médicale digestive

    Toulouse, 31059

Other trials in France

Bulgaria9 sites

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

    Burgas, 8000

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

    Gabrovo, 5300

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

    Plovdiv, 4004

  • "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department

    Sofia, 1330

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

    Sofia, 1431

  • MHAT Serdika EOOD Department of Medical Oncology

    Sofia, 1632

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

    Sofia, 1756

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

    Varna, 9003

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

    Vratsa, 3000

Other trials in Bulgaria

Poland8 sites

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

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Przychodnia Lekarska "KOMED"

    Konin, 62-500

  • M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow

    Lodz, 93-513

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

    Olsztyn, 10-228

  • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

    Opole, 45-061

  • Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

    Poznan, 61-866

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

    Tomaszów Mazowiecki, 97-200

Other trials in Poland

Romania8 sites

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

    Bucharest, 022328

  • Spitalul Clinic "Coltea" Sectia Oncologie Medicala

    Bucharest, 030171

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

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sf Nectarie Oncology Department

    Craiova, 200347

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

    Craiova, 200385

  • Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

    Iași, 700483

  • Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala

    Sibiu, 550245

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

    Timișoara, 300239

Other trials in Romania

Australia6 sites

  • Blacktown Hospital Cancer and Haematology Centre

    Blacktown, 2148

  • Frankston Private Peninsula and Southeast Oncology Group

    Frankston, 3199

  • Lake Macquarie Private Hospital

    Gateshead, 2290

  • St George Hospital St George Hospital Cancer Care Centre

    Kogarah, 2217

  • Adventist HealthCare Integrated Cancer Centre

    Wahroonga, 2076

  • Southern Medical Day Care Centre

    Wollongong, 2500

Other trials in Australia

Austria6 sites

  • Med. Universität Graz Klinische Abteilung für Onkologie

    Graz, 8036

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

    Innsbruck, 6020

  • Ordensklinikum Linz Barmherzige Schwestern Interne I

    Linz, 4010

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

    Salzburg, 5020

  • Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I

    Sankt Pölten, 3100

  • Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

    Vienna, 1090

Other trials in Austria

Netherlands6 sites

  • Rijnstate Oncologie

    Arnhem, 6815 AD

  • Albert Schweitzer Ziekenhuis Interne Geneeskunde

    Dordrecht, 3318 AT

  • Catharina Ziekenhuis Interne Gesneeskunde/Oncologie

    Eindhoven, 5623 EJ

  • Ikazia Ziekenhuis Oncologie

    Rotterdam, 3083 AN

  • ETZ Elisabeth Interne Geneeskunde

    Tilburg, 5022 GC

  • Bernhoven Interne Geneeskunde

    Uden, 5406 PT

Other trials in Netherlands

Czechia5 sites

  • Masarykuv onkologicky ustav Klinika komplexni onkologicke pece

    Brno, 656 53

  • Fakultni nemocnice Ostrava Klinika onkologicka

    Ostrava

  • Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK

    Prague, 128 08

  • Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN

    Prague, 140 59

  • Fakultni nemocnice Olomouc Onkologicka klinika

    Prague, 77900

Other trials in Czechia

Portugal5 sites

  • Hospital Garcia de Orta Serviço de Oncologia Médica

    Almada, 2805-267

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

    Coimbra, 3000-075

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

    Lisbon, 1649-035

  • Hospital Beatriz Ângelo Serviço de oncologia medic

    Loures, 2674-514

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

    Porto, 4200-072

Other trials in Portugal

Sweden5 sites

  • Falu Lasarett Onkologmottagningen

    Falun, 791 82

  • Lanssjukhuset Ryhov Onkologiska kliniken

    Jönköping, 551 85

  • Universitetssjukhuset Orebro

    Örebro, 701 85

  • Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09

    Solna, 171 64

  • Norrlands Universitetssjukhus Cancercentrum Umea

    Umeå, 901 85

Other trials in Sweden

Denmark4 sites

  • Aalborg Universitetshospital, Syd Onkologisk Afdelin

    Aalborg, 9000

  • Rigshospitalet Onkologisk Klinik

    Copenhagen, 2100

  • Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling

    Herning, 7400

  • Odense Universitetshospital Onkologisk Afdeling R

    Odense, 5000

Other trials in Denmark

Lithuania4 sites

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

    Kaunas, 45434

  • Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute

    Kaunas, LT-50161

  • Klaipeda University hospital

    Klaipėda, 92288

  • National Cancer Institute

    Vilnius, LT-08660

Other trials in Lithuania

Estonia3 sites

  • East Tallinn Central Hospital Center of Oncology

    Tallinn, 11312

  • North Estonia Medical Centre Foundation Oncology and Haematology clinic

    Tallinn, 13419

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

    Tartu, 51014

Other trials in Estonia

Germany3 sites

  • Onkologische Schwerpunktpraxis Kurfuerstendamm

    Berlin, 10707

  • Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

    Lübeck, 23562

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

    München, 81377

Other trials in Germany

Ireland3 sites

  • Bon Secours Hospital

    Cork, 90

  • Cork University Hospital Department of Medical Oncology

    Cork, T12 DC4A

  • The Adelaide and Meath Hospital

    Dublin, D24 NROA

Other trials in Ireland

Latvia2 sites

  • P. Stradins Clinical University Hospital

    Riga, 1002

  • Riga East Univerity Hospital Oncology Centre of Latvia

    Riga, 1079

Other trials in Latvia

Slovakia2 sites

  • Narodny onkologicky ustav Oddelenie klinickej onkologie

    Bratislava, 833 10

  • Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

    Košice, 04191

Other trials in Slovakia

About this study

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)

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

Being tested
Trifluridine/tipiracil hydrochloride (S95005), Capecitabine, Bevacizumab experimental, Bevacizumab control
Keywords
Metastatic, Cancer, Colorectal, Colorectal Cancer, Colon, Rectum, Metastasis
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trifluridine/tipiracil hydrochloride (S95005)Drug

    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.

  • CapecitabineDrug

    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 experimentalBiological

    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 controlBiological

    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.

Study groups in NCT03869892
Study groupRoleWhat they receive
S95005 + BevacizumabExperimentalNot described
Receives: Drug: Trifluridine/tipiracil hydrochloride (S95005); Biological: Bevacizumab experimental
Capecitabine + BevacizumabActive comparatorNot described
Receives: Drug: Capecitabine; Biological: Bevacizumab control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.

    Measured: Up to 24 months

Secondary outcomes (12)

  1. Overall Survival (OS)

    Time elapsed between the date of randomization and the date of death due to any cause.

    Measured: Up to 8 years

  2. Overall response rate (ORR)

    The proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and using investigator's tumour assessment.

    Measured: Up to 8 years

  3. Disease control rate (DCR)

    The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 criteria and using investigator's tumour assessment.

    Measured: Up to 8 years

  4. Duration of response (DoR)

    The time from the first documentation of response (CR or PR) to the first documentation of objective tumour progression or death due to any cause, whichever occurs first.

    Measured: Up to 8 years

  5. Time to treatment failure (TTF)

    The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

    Measured: Up to 8 years

  6. Incidence of Adverse Events (AEs)

    Measured: Up to 8 years

  7. Number of clinically significant changes to hematology, biochemistry, coagulation and urinalysis tests

    Measured: Up to 8 years

  8. Changes in ECOG performance status

    Measured: Up to 8 years

  9. Number of clinically significant changes to blood pressure, heart rate, body temperature and body weight

    Measured: Up to 8 years

  10. Number of clinically significant changes to 12-leads ECG parameters

    Measured: Up to 8 years

  11. Quality of life as assessed by EORTC QLQ-C30

    European organization for research and treatment of cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) scores range from 0-100 and assess functional and symptom scores. For functional scores, a higher score represents an increase in functioning. For symptom scores, a higher score represents an increase in symptoms.

    Measured: Up to 8 years

  12. Quality of life as assessed by EQ-5D-5L

    The 5-level EQ-5D version questionnaire scores range from 5 to 25 with a higher score representing a worse health status.

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start21 Mar 2019
  3. Primary completion29 Jun 2021
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
856 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03869892
Sponsor's protocol ID
CL3-95005-006
Other IDs
2017-004059-22, U1111-1206-3198, 2017
Acronym
SOLSTICE
Status last verified
Dec 2025
First submitted
23 Feb 2018
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Publications

  • Andre T, Falcone A, Shparyk Y, Moiseenko F, Polo-Marques E, Csoszi T, Campos-Bragagnoli A, Liposits G, Chmielowska E, Aubel P, Martin L, Fougeray R, Amellal N, Saunders MP. Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):133-144. doi: 10.1016/S2468-1253(22)00334-X. Epub 2022 Dec 2.

    PubMed 36470291

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trifluridine/tipiracil hydrochloride (S95005), Capecitabine and Bevacizumab experimental in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 190 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in Russia, Hungary, Spain, Italy, Ukraine and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03869892, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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