Clinical trial NCT03869892: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic
Cancer
Colorectal
Colorectal Cancer
Colon
Rectum
Metastasis
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2019-03-11
Enrollment: 856
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
2. 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).
3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
4. Patient is not a candidate for curative resection of metastatic lesions.
5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

   Exclusion Criteria:
8. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
9. Participation in another interventional study within 4 weeks prior to the randomisation .
10. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
11. Symptomatic central nervous system metastases.
12. Major surgery within 4 weeks prior to the randomisation.

    Exclusion criteria related to S 95005 administration:
13. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
14. Any contraindication present in the SmPC of trifluridine/tipiracil

    Exclusion criteria related to bevacizumab administration:
15. Any contraindication present in the SmPC of bevacizumab

    Exclusion criteria related to capecitabine administration:
16. Any contraindication present in the SmPC of capecitabine

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 24 months
measure: Overall response rate (ORR)
timeFrame: Up to 24 months
measure: Disease control rate (DCR)
timeFrame: Up to 24 months
measure: Duration of response (DoR)
timeFrame: Up to 24 months
measure: Time to treatment failure (TTF)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Berazategui
country: Argentina
facility: Centro de Oncología e Investigación de Buenos Aires COIBA
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro Oncology Unit
city: Ciudad Autonoma de Buenos aires
country: Argentina
facility: Instituto Alexander Fleming
city: Ciudad Autonoma de Buenos aires
country: Argentina
facility: Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit
city: La Rioja
country: Argentina
facility: Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer
city: Mendoza
country: Argentina
facility: Fundación COIR Centro Oncológico de Interación Regional
city: Santa Fe
country: Argentina
facility: Instituto de Oncología de Rosario
city: Santa Fe
country: Argentina
facility: ISIS Centro especializado
city: Tucumán
country: Argentina
facility: Centro Médico San Roque
city: Blacktown
country: Australia
facility: Blacktown Hospital Cancer and Haematology Centre
city: Frankston
country: Australia
facility: Frankston Private Peninsula and Southeast Oncology Group
city: Gateshead
country: Australia
facility: Lake Macquarie Private Hospital
city: Kogarah
country: Australia
facility: St George Hospital St George Hospital Cancer Care Centre
city: Wahroonga
country: Australia
facility: Adventist HealthCare Integrated Cancer Centre
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
city: Graz
country: Austria
facility: Med. Universität Graz Klinische Abteilung für Onkologie
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern Interne I
city: Salzburg
country: Austria
facility: Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)
city: St. Poelten
country: Austria
facility: Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I
city: Wien
country: Austria
facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie
city: Barretos
country: Brazil
facility: Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica
city: Belo Horizonte
country: Brazil
facility: Cenantron - Clinica
city: Brasília
country: Brazil
facility: Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa
city: Ijuí
country: Brazil
facility: Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus Oncologia
city: Salvador
country: Brazil
facility: Hospital São Rafael Centro Intergrado de Pesquisa
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base Centro Integrado de Pesquisa
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa
city: São Paulo
country: Brazil
facility: Hospital A C Camargo Unidade de Pesquisa Clinica
city: Burgas
country: Bulgaria
facility: "Complex oncology center - Burgas" EOOD Department of medical oncology
city: Gabrovo
country: Bulgaria
facility: "Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology
city: Plovdiv
country: Bulgaria
facility: "Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology
city: Sofia
country: Bulgaria
facility: "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department
city: Sofia
country: Bulgaria
facility: "UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology
city: Sofia
country: Bulgaria
facility: MHAT Serdika EOOD Department of Medical Oncology
city: Sofia
country: Bulgaria
facility: Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care
city: Varna
country: Bulgaria
facility: SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy
city: Vratsa
country: Bulgaria
facility: "Complex Ongology Center - Vratsa" EOOD Department of Medical oncology
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav Klinika komplexni onkologicke pece
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava Klinika onkologicka
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK
city: Praha
country: Czechia
facility: Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN
city: Praha
country: Czechia
facility: Fakultni nemocnice Olomouc Onkologicka klinika
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd Onkologisk Afdelin
city: Herning
country: Denmark
facility: Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling
city: Kobenhavn
country: Denmark
facility: Rigshospitalet Onkologisk Klinik
city: Odense
country: Denmark
facility: Odense Universitetshospital Onkologisk Afdeling R
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Center of Oncology
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation Oncology and Haematology clinic
city: Tartu
country: Estonia
facility: Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: CHU Jean Minjoz Service d'oncologie médicale
city: Brest
country: France
facility: CHU Morvan Institut de Cancérologie et d'Hématologie
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
city: Montbeliard
country: France
facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
city: Nice
country: France
facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale
city: Paris
country: France
facility: Hôpital Saint-Antoine Service d'Oncologie Médicale
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
city: Pessac
country: France
facility: Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive
city: Toulouse
country: France
facility: CHU Toulouse Rangueil Oncologie médicale digestive
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfuerstendamm
city: Luebeck
country: Germany
facility: Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
city: Muenchen
country: Germany
facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly
city: Budapest
country: Hungary
facility: Semmelweis University Radiology and Oncotherapy Clinic
city: Budapest
country: Hungary
facility: Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely
city: Budapest
country: Hungary
facility: Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz Onkoradiologiai Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Győr
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
city: Szolnok
country: Hungary
facility: JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
city: Szombathely
country: Hungary
facility: Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz Onkologiai osztaly
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital Department of Medical Oncology
city: Dublin
country: Ireland
facility: The Adelaide and Meath Hospital
city: Cagliari
country: Italy
facility: Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
city: Pisa
country: Italy
facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
city: Potenza
country: Italy
facility: Ospedale San Carlo U.O. Oncologia Medica
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova Unità di Oncologia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica
city: Rozzano (mi)
country: Italy
facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia
city: San Giovanni Rotondo
country: Italy
facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Univerity Hospital Oncology Centre of Latvia
city: Kaunas
country: Lithuania
facility: Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos
city: Kaunas
country: Lithuania
facility: Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute
city: Klaipėda
country: Lithuania
facility: Klaipeda University hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Arnhem
country: Netherlands
facility: Rijnstate Oncologie
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis Interne Geneeskunde
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Interne Gesneeskunde/Oncologie
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis Oncologie
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth Interne Geneeskunde
city: Uden
country: Netherlands
facility: Bernhoven Interne Geneeskunde
city: Białystok
country: Poland
facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
city: Konin
country: Poland
facility: Przychodnia Lekarska "KOMED"
city: Olsztyn
country: Poland
facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
city: Tomaszów Mazowiecki
country: Poland
facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi
city: Łódź
country: Poland
facility: M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow
city: Almada
country: Portugal
facility: Hospital Garcia de Orta Serviço de Oncologia Médica
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, Hospital de Santa Maria Serviço de Oncologia Médica
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo Serviço de oncologia medic
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.
city: Bucuresti
country: Romania
facility: Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Coltea" Sectia Oncologie Medicala
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie Oncology Department
city: Craiova
country: Romania
facility: S.C Oncolab S.R.L Sectia Oncologie Medicala
city: Iaşi
country: Romania
facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala
city: Timişoara
country: Romania
facility: S.C ONCOMED S.R.L Departament Oncologie Medicala
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Dispensary chemotherapy department
city: Krasnodar
country: Russian Federation
facility: Clinical Oncology Dispensary No.1 Chemotherapy Department
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary Oncology Department
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
city: Moscow
country: Russian Federation
facility: University Headache Clinic Outpatient oncology clinic
city: Moscow
country: Russian Federation
facility: Moscow City Oncology Hospital # 62 chemotherapy department
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncologic Dispensary Chemotherapy
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Research Institute of Oncology Chemotherapy department
city: Ryazan'
country: Russian Federation
facility: Regional Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
city: Saint Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.N. Petrova
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg City Oncology Clilnic
city: Samara
country: Russian Federation
facility: Multidisciplinary clinic "Reaviz"
city: Sochi
country: Russian Federation
facility: Oncology Dispensary No.2
city: Tomsk
country: Russian Federation
facility: State Research Institution of Oncology of Tomsk Chemotherapy
city: Yaroslavl
country: Russian Federation
facility: SBIH of YR "Clinical oncology hospital" chemotherapy department
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav Oddelenie klinickej onkologie
city: Košice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante Servicio de Oncología
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica
city: Barcelona
country: Spain
facility: H. Valle de Hebrón Servicio de Oncología - (VHIR)
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau Oncología Medica
city: Córdoba
country: Spain
facility: Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica
city: Hospitalet de Llobregat
country: Spain
facility: INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica
city: Madrid
country: Spain
facility: Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica
city: Madrid
country: Spain
facility: H. Clínico San Carlos Servicio de Oncología Médica
city: Madrid
country: Spain
facility: HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica
city: Madrid
country: Spain
facility: H. Universitario La Paz Oncología Médica
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla Oncología médica
city: Sevilla
country: Spain
facility: H.Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Quirónsalud Valencia Servicio de Oncología Médica
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet Servicio de Oncología
city: Falun
country: Sweden
facility: Falu Lasarett Onkologmottagningen
city: Jönköping
country: Sweden
facility: Lanssjukhuset Ryhov Onkologiska kliniken
city: Solna
country: Sweden
facility: Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus Cancercentrum Umea
city: Örebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
city: Dnipro
country: Ukraine
facility: Dnipro Regional Oncology Dispensary
city: Dnipro
country: Ukraine
facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology
city: Kharkiv
country: Ukraine
facility: Institute of Medical Radiology of S.P. Grygoryev of AMS UKR
city: Kyiv
country: Ukraine
facility: National Institute of Cancer Abdominal Oncology Department
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre Chemotherapy Department #2
city: Kyiv
country: Ukraine
facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department
city: Lviv
country: Ukraine
facility: Lviv Regional Oncology Center Chemotherapy department
city: Odesa
country: Ukraine
facility: Odesa Regional Oncology Dispensary Day patient Department
city: Vinnytsya
country: Ukraine
facility: Podillia Regional Oncology Centre Chemotherapy Department
city: Zaporozhye
country: Ukraine
facility: Regional Clinical Oncological Dispensary Department of Oncology
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary Oncology Department
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol Bristol Haematology & Oncology Centre
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary The HOPE Clinical Trials Unit
city: London
country: United Kingdom
facility: Royal Marsden Hospital Department of Medicine
city: London
country: United Kingdom
facility: Hammersmith Hospital Gary Weston Centre
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK Clinical Trials
city: London
country: United Kingdom
facility: Imperial Healthcare NHS Trust Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust GI & Endocrine
city: Rhyl
country: United Kingdom
facility: Glan Clwyd Hospital North Wales Cancer Treatment Centre
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital Department of Medicine
Study officials:
affiliation: Medical Oncology departement Saint-Antoine hospital (Paris France 75012)
name: Thierry ANDRE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.