Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
SOLSTICE
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)
3 other identifiers
interventional
856
23 countries
181
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2019
Longer than P75 for phase_3
181 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
March 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 22, 2025
December 1, 2025
2.3 years
February 23, 2018
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to 24 months
Secondary Outcomes (12)
Overall Survival (OS)
Up to 8 years
Overall response rate (ORR)
Up to 8 years
Disease control rate (DCR)
Up to 8 years
Duration of response (DoR)
Up to 8 years
Time to treatment failure (TTF)
Up to 8 years
- +7 more secondary outcomes
Study Arms (2)
S95005 + Bevacizumab
EXPERIMENTALCapecitabine + Bevacizumab
ACTIVE COMPARATORInterventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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'
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (190)
Centro de Oncología e Investigación de Buenos Aires COIBA
Berazategui, B1884BBF, Argentina
Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit
Buenos Aires, 1264, Argentina
Fundación Favaloro Oncology Unit
Buenos Aires, C1093AAS, Argentina
Instituto Alexander Fleming
Buenos Aires, C1426ANZ, Argentina
Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales
Buenos Aires, C1431FWO, Argentina
Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE, Argentina
Fundación COIR Centro Oncológico de Interación Regional
Mendoza, 5500, Argentina
Centro Médico San Roque
San Miguel de Tucumán, T4000IAK, Argentina
Instituto de Oncología de Rosario
Santa Fe, S2000KZE, Argentina
ISIS Centro especializado
Santa Fe, S3000FFU, Argentina
Blacktown Hospital Cancer and Haematology Centre
Blacktown, 2148, Australia
Frankston Private Peninsula and Southeast Oncology Group
Frankston, 3199, Australia
Lake Macquarie Private Hospital
Gateshead, 2290, Australia
St George Hospital St George Hospital Cancer Care Centre
Kogarah, 2217, Australia
Adventist HealthCare Integrated Cancer Centre
Wahroonga, 2076, Australia
Southern Medical Day Care Centre
Wollongong, 2500, Australia
Med. Universität Graz Klinische Abteilung für Onkologie
Graz, 8036, Austria
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V
Innsbruck, 6020, Austria
Ordensklinikum Linz Barmherzige Schwestern Interne I
Linz, 4010, Austria
Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)
Salzburg, 5020, Austria
Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I
Sankt Pölten, 3100, Austria
Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie
Vienna, 1090, Austria
Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica
Barretos, 14784-400, Brazil
Cenantron - Clinica
Belo Horizonte, 30150-320, Brazil
Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa
Brasília, 70200-730, Brazil
Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica
Ijuí, 98700-000, Brazil
Hospital Mae de Deus Oncologia
Porto Alegre, 90880-480, Brazil
Hospital São Rafael Centro Intergrado de Pesquisa
Salvador, 41253-191, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa
Santo André, 09060-870, Brazil
Hospital de Base Centro Integrado de Pesquisa
São José do Rio Preto, 15090-000, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa
São Paulo, 01246-000, Brazil
Hospital A C Camargo Unidade de Pesquisa Clinica
São Paulo, 01509-900, Brazil
"Complex oncology center - Burgas" EOOD Department of medical oncology
Burgas, 8000, Bulgaria
"Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology
Gabrovo, 5300, Bulgaria
"Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology
Plovdiv, 4004, Bulgaria
"Medical Center Nadezhda Clinical" EOOD Medical Oncology Department
Sofia, 1330, Bulgaria
"UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology
Sofia, 1431, Bulgaria
MHAT Serdika EOOD Department of Medical Oncology
Sofia, 1632, Bulgaria
Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care
Sofia, 1756, Bulgaria
SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy
Varna, 9003, Bulgaria
"Complex Ongology Center - Vratsa" EOOD Department of Medical oncology
Vratsa, 3000, Bulgaria
Masarykuv onkologicky ustav Klinika komplexni onkologicke pece
Brno, 656 53, Czechia
Fakultni nemocnice Ostrava Klinika onkologicka
Ostrava, Czechia
Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK
Prague, 128 08, Czechia
Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN
Prague, 140 59, Czechia
Fakultni nemocnice Olomouc Onkologicka klinika
Prague, 77900, Czechia
Aalborg Universitetshospital, Syd Onkologisk Afdelin
Aalborg, 9000, Denmark
Rigshospitalet Onkologisk Klinik
Copenhagen, 2100, Denmark
Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling
Herning, 7400, Denmark
Odense Universitetshospital Onkologisk Afdeling R
Odense, 5000, Denmark
East Tallinn Central Hospital Center of Oncology
Tallinn, 11312, Estonia
North Estonia Medical Centre Foundation Oncology and Haematology clinic
Tallinn, 13419, Estonia
Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy
Tartu, 51014, Estonia
Institut Sainte Catherine
Avignon, 84918, France
CHU Jean Minjoz Service d'oncologie médicale
Besançon, 25030, France
CHU Morvan Institut de Cancérologie et d'Hématologie
Brest, 29200, France
Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale
Lyon, 69008, France
Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale
Montbéliard, 25209, France
Centre Antoine Lacassagne Dpt d'Oncologie Médicale
Nice, 06189, France
Hôpital Saint-Antoine Service d'Oncologie Médicale
Paris, 75012, France
Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive
Paris, 75015, France
Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive
Pessac, 33604, France
CHU Toulouse Rangueil Oncologie médicale digestive
Toulouse, 31059, France
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, 10707, Germany
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
Lübeck, 23562, Germany
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
München, 81377, Germany
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly
Budapest, 1062, Hungary
Semmelweis University Radiology and Oncotherapy Clinic
Budapest, 1083, Hungary
Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely
Budapest, 1097, Hungary
Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia
Budapest, 1115, Hungary
Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.
Budapest, 1122, Hungary
Uzsoki Utcai Korhaz Onkoradiologiai Osztaly
Budapest, 1145, Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
Győr, 9024, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, 57000, Hungary
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
Szeged, 6720, Hungary
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
Szolnok, 5004, Hungary
Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
Szombathely, 9700, Hungary
Zala Megyei Korhaz Onkologiai osztaly
Zalaegerszeg, 8900, Hungary
Bon Secours Hospital
Cork, 90, Ireland
Cork University Hospital Department of Medical Oncology
Cork, T12 DC4A, Ireland
The Adelaide and Meath Hospital
Dublin, D24 NROA, Ireland
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica
Cagliari, 09100, Italy
Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA
Cremona, 26100, Italy
Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale
Naples, 80131, Italy
Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1
Padua, 35128, Italy
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
Pisa, 56126, Italy
Ospedale San Carlo U.O. Oncologia Medica
Potenza, 85100, Italy
Arcispedale Santa Maria Nuova Unità di Oncologia
Reggio Emilia, 42123, Italy
Policlinico Universitario Campus Biomedico UOC di Oncologia Medica
Roma, 00128, Italy
Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia
Rozzano (MI), 20089, Italy
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia
San Giovanni Rotondo, 71013, Italy
Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA
Vicenza, 36100, Italy
P. Stradins Clinical University Hospital
Riga, 1002, Latvia
Riga East Univerity Hospital Oncology Centre of Latvia
Riga, 1079, Latvia
Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos
Kaunas, 45434, Lithuania
Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute
Kaunas, LT-50161, Lithuania
Klaipeda University hospital
Klaipėda, 92288, Lithuania
National Cancer Institute
Vilnius, LT-08660, Lithuania
Rijnstate Oncologie
Arnhem, 6815 AD, Netherlands
Albert Schweitzer Ziekenhuis Interne Geneeskunde
Dordrecht, 3318 AT, Netherlands
Catharina Ziekenhuis Interne Gesneeskunde/Oncologie
Eindhoven, 5623 EJ, Netherlands
Ikazia Ziekenhuis Oncologie
Rotterdam, 3083 AN, Netherlands
ETZ Elisabeth Interne Geneeskunde
Tilburg, 5022 GC, Netherlands
Bernhoven Interne Geneeskunde
Uden, 5406 PT, Netherlands
Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej
Bialystok, 15-027, Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Przychodnia Lekarska "KOMED"
Konin, 62-500, Poland
M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow
Lodz, 93-513, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii
Olsztyn, 10-228, Poland
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
Opole, 45-061, Poland
Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii
Poznan, 61-866, Poland
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi
Tomaszów Mazowiecki, 97-200, Poland
Hospital Garcia de Orta Serviço de Oncologia Médica
Almada, 2805-267, Portugal
Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)
Coimbra, 3000-075, Portugal
Centro Hospitalar Lisboa Norte, Hospital de Santa Maria Serviço de Oncologia Médica
Lisbon, 1649-035, Portugal
Hospital Beatriz Ângelo Serviço de oncologia medic
Loures, 2674-514, Portugal
Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.
Porto, 4200-072, Portugal
Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I
Bucharest, 022328, Romania
Spitalul Clinic "Coltea" Sectia Oncologie Medicala
Bucharest, 030171, Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sf Nectarie Oncology Department
Craiova, 200347, Romania
S.C Oncolab S.R.L Sectia Oncologie Medicala
Craiova, 200385, Romania
Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala
Iași, 700483, Romania
Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala
Sibiu, 550245, Romania
S.C ONCOMED S.R.L Departament Oncologie Medicala
Timișoara, 300239, Romania
Arkhangelsk Clinical Oncology Dispensary chemotherapy department
Arkhangelsk, 163045, Russia
Clinical Oncology Dispensary No.1 Chemotherapy Department
Krasnodar, 350040, Russia
Kursk Regional Clinical Oncology Dispensary Oncology Department
Kursk, 305524, Russia
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
Moscow, 115478, Russia
University Headache Clinic Outpatient oncology clinic
Moscow, 121467, Russia
Moscow City Oncology Hospital # 62 chemotherapy department
Moscow, 143423, Russia
Omsk Clinical Oncologic Dispensary Chemotherapy
Omsk, 644046, Russia
Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department
Pyatigorsk, 357502, Russia
Rostov Research Institute of Oncology Chemotherapy department
Rostov-on-Don, 344037, Russia
Regional Clinical Oncology Dispensary
Ryazan, 390011, Russia
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
Saint Petersburg, 115478, Russia
National Medical Research Center of Oncology N.N. Petrova
Saint Petersburg, 197758, Russia
Saint Petersburg City Oncology Clilnic
Saint Petersburg, 198255, Russia
Multidisciplinary clinic "Reaviz"
Samara, 443011, Russia
Oncology Dispensary No.2
Sochi, 354057, Russia
State Research Institution of Oncology of Tomsk Chemotherapy
Tomsk, 634024, Russia
SBIH of YR "Clinical oncology hospital" chemotherapy department
Yaroslavl, 150054, Russia
Narodny onkologicky ustav Oddelenie klinickej onkologie
Bratislava, 833 10, Slovakia
Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie
Košice, 04191, Slovakia
Hospital General Universitario Alicante Servicio de Oncología
Alicante, 03010, Spain
Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica
Badalona, 08916, Spain
H. Valle de Hebrón Servicio de Oncología - (VHIR)
Barcelona, 08035, Spain
Hospital de la Santa Creu I Sant Pau Oncología Medica
Barcelona, 08041, Spain
Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica
Córdoba, 14004, Spain
INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica
L'Hospitalet de Llobregat, 08908, Spain
Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica
Madrid, 28034, Spain
H. Clínico San Carlos Servicio de Oncología Médica
Madrid, 28040, Spain
HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica
Madrid, 28041, Spain
H. Universitario La Paz Oncología Médica
Madrid, 28046, Spain
Hospital Universitario Marqués de Valdecilla Oncología médica
Santander, 39008, Spain
H.Virgen Del Rocio
Seville, 41013, Spain
Hospital Quirónsalud Valencia Servicio de Oncología Médica
Valencia, 46010, Spain
Hospital Universitario Miguel Servet Servicio de Oncología
Zaragoza, 50009, Spain
Falu Lasarett Onkologmottagningen
Falun, 791 82, Sweden
Lanssjukhuset Ryhov Onkologiska kliniken
Jönköping, 551 85, Sweden
Universitetssjukhuset Orebro
Örebro, 701 85, Sweden
Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09
Solna, 171 64, Sweden
Norrlands Universitetssjukhus Cancercentrum Umea
Umeå, 901 85, Sweden
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
Cherkasy, 18009, Ukraine
Dnipro Regional Oncology Dispensary
Dnipro, 49055, Ukraine
MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology
Dnipro, 49102, Ukraine
Institute of Medical Radiology of S.P. Grygoryev of AMS UKR
Kharkiv, 61024, Ukraine
National Institute of Cancer Abdominal Oncology Department
Kyiv, 03022, Ukraine
Kyiv City Clinical Oncology Centre Chemotherapy Department #2
Kyiv, 03115, Ukraine
Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department
Kyiv, 04107, Ukraine
Lviv Regional Oncology Center Chemotherapy department
Lviv, 79031, Ukraine
Odesa Regional Oncology Dispensary Day patient Department
Odesa, 65010, Ukraine
Podillia Regional Oncology Centre Chemotherapy Department
Vinnytsia, 21029, Ukraine
Regional Clinical Oncological Dispensary Department of Oncology
Zaporizhzhya, 69000, Ukraine
Aberdeen Royal Infirmary Oncology Department
Aberdeen, AB25 2ZN, United Kingdom
University Hospitals Bristol Bristol Haematology & Oncology Centre
Bristol, BS2 8ED, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary The HOPE Clinical Trials Unit
Leicester, LE1 5WW, United Kingdom
Royal Marsden Hospital Department of Medicine
London, SW3 6JJ, United Kingdom
Hammersmith Hospital Gary Weston Centre
London, W12 0HS, United Kingdom
Sarah Cannon Research Institute UK Clinical Trials
London, W1G 6AD, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital
London, W6 8RF, United Kingdom
Christie Hospital NHS Foundation Trust GI & Endocrine
Manchester, M20 4BX, United Kingdom
Glan Clwyd Hospital North Wales Cancer Treatment Centre
Rhyl, LL18 5UJ, United Kingdom
Royal Marsden Hospital Department of Medicine
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 36470291BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry ANDRE, PhD
Medical Oncology departement Saint-Antoine hospital (Paris France 75012)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 11, 2019
Study Start
March 21, 2019
Primary Completion
June 29, 2021
Study Completion (Estimated)
December 31, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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.