Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. (SOLSTICE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03869892 |
Recruitment Status :
Active, not recruiting
First Posted : March 11, 2019
Last Update Posted : April 15, 2022
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Colorectal Cancer | Drug: Trifluridine/tipiracil hydrochloride (S95005) Drug: Capecitabine Biological: Bevacizumab experimental Biological: Bevacizumab control | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 856 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | March 21, 2019 |
Estimated Primary Completion Date : | September 18, 2022 |
Estimated Study Completion Date : | September 18, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: S95005 + Bevacizumab |
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. 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. |
Active Comparator: Capecitabine + Bevacizumab |
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 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. |
- Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.
- Overall Survival (OS) [ Time Frame: Up to 24 months ]Time elapsed between the date of randomization and the date of death due to any cause.
- Overall response rate (ORR) [ Time Frame: Up to 24 months ]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.
- Disease control rate (DCR) [ Time Frame: Up to 24 months ]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.
- Duration of response (DoR) [ Time Frame: Up to 24 months ]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.
- Time to treatment failure (TTF) [ Time Frame: Up to 24 months ]The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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'
Exclusion Criteria:
- 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.
Exclusion criteria related to S 95005 administration:
- 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
Exclusion criteria related to bevacizumab administration:
-
Any contraindication present in the SmPC of bevacizumab
Exclusion criteria related to capecitabine administration:
- Any contraindication present in the SmPC of capecitabine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869892

Argentina | |
Centro de Oncología e Investigación de Buenos Aires COIBA | |
Berazategui, Argentina, B1884BBF | |
Fundación Favaloro Oncology Unit | |
Buenos Aires, Argentina, C1093AAS | |
Instituto Alexander Fleming | |
Ciudad Autonoma de Buenos aires, Argentina, C1426ANZ | |
Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales | |
Ciudad Autonoma de Buenos aires, Argentina, C1431FWO | |
Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit | |
Ciudad Autónoma de Buenos Aires, Argentina, 1264 | |
Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer | |
La Rioja, Argentina, F5300COE | |
Fundación COIR Centro Oncológico de Interación Regional | |
Mendoza, Argentina, 5500 | |
Instituto de Oncología de Rosario | |
Santa Fe, Argentina, S2000KZE | |
ISIS Centro especializado | |
Santa Fe, Argentina, S3000FFU | |
Centro Médico San Roque | |
Tucumán, Argentina, T4000IAK | |
Australia | |
Blacktown Hospital Cancer and Haematology Centre | |
Blacktown, Australia, 2148 | |
Frankston Private Peninsula and Southeast Oncology Group | |
Frankston, Australia, 3199 | |
Lake Macquarie Private Hospital | |
Gateshead, Australia, 2290 | |
St George Hospital St George Hospital Cancer Care Centre | |
Kogarah, Australia, 2217 | |
Adventist HealthCare Integrated Cancer Centre | |
Wahroonga, Australia, 2076 | |
Southern Medical Day Care Centre | |
Wollongong, Australia, 2500 | |
Austria | |
Med. Universität Graz Klinische Abteilung für Onkologie | |
Graz, Austria, 8036 | |
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V | |
Innsbruck, Austria, 6020 | |
Ordensklinikum Linz Barmherzige Schwestern Interne I | |
Linz, Austria, 4010 | |
Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK) | |
Salzburg, Austria, 5020 | |
Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I | |
St. Poelten, Austria, 3100 | |
Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie | |
Wien, Austria, 1090 | |
Brazil | |
Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica | |
Barretos, Brazil, 14784-400 | |
Cenantron - Clinica | |
Belo Horizonte, Brazil, 30150-320 | |
Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa | |
Brasília, Brazil, 70200-730 | |
Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica | |
Ijuí, Brazil, 98700-000 | |
Hospital Mae de Deus Oncologia | |
Porto Alegre, Brazil, 90880-480 | |
Hospital São Rafael Centro Intergrado de Pesquisa | |
Salvador, Brazil, 41253-191 | |
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa | |
Santo André, Brazil, 09060-870 | |
Hospital de Base Centro Integrado de Pesquisa | |
São José Do Rio Preto, Brazil, 15090-000 | |
ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa | |
São Paulo, Brazil, 01246-000 | |
Hospital A C Camargo Unidade de Pesquisa Clinica | |
São Paulo, Brazil, 01509-900 | |
Bulgaria | |
"Complex oncology center - Burgas" EOOD Department of medical oncology | |
Burgas, Bulgaria, 8000 | |
"Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology | |
Gabrovo, Bulgaria, 5300 | |
"Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology | |
Plovdiv, Bulgaria, 4004 | |
"Spec. hospital for active treatment of oncology dis." EOOD Department of medical oncology and palliative care | |
Sofia, Bulgaria, 1233 | |
"Medical Center Nadezhda Clinical" EOOD Medical Oncology Department | |
Sofia, Bulgaria, 1330 | |
"UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology | |
Sofia, Bulgaria, 1431 | |
MHAT Serdika EOOD Department of Medical Oncology | |
Sofia, Bulgaria, 1632 | |
Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative car | |
Sofia, Bulgaria, 1756 | |
SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy | |
Varna, Bulgaria, 9003 | |
"Complex Ongology Center - Vratsa" EOOD Department of Medical oncology | |
Vratsa, Bulgaria, 3000 | |
Czechia | |
Masarykuv onkologicky ustav Klinika komplexni onkologicke pece | |
Brno, Czechia, 656 53 | |
Fakultni nemocnice Ostrava Klinika onkologicka | |
Ostrava, Czechia | |
Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK | |
Praha, Czechia, 128 08 | |
Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN | |
Praha, Czechia, 140 59 | |
Fakultni nemocnice Olomouc Onkologicka klinika | |
Praha, Czechia, 77900 | |
Denmark | |
Aalborg Universitetshospital, Syd Onkologisk Afdelin | |
Aalborg, Denmark, 9000 | |
Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling | |
Herning, Denmark, 7400 | |
Rigshospitalet Onkologisk Klinik | |
Kobenhavn, Denmark, 2100 | |
Odense Universitetshospital Onkologisk Afdeling R | |
Odense, Denmark, 5000 | |
Estonia | |
East Tallinn Central Hospital Center of Oncology | |
Tallinn, Estonia, 11312 | |
North Estonia Medical Centre Foundation Oncology and Haematology clinic | |
Tallinn, Estonia, 13419 | |
Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy | |
Tartu, Estonia, 51014 | |
France | |
Institut Sainte Catherine | |
Avignon, France, 84918 | |
CHU Jean Minjoz Service d'oncologie médicale | |
Besancon, France, 25030 | |
CHU Morvan Institut de Cancérologie et d'Hématologie | |
Brest, France, 29200 | |
Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale | |
Lyon, France, 69008 | |
Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale | |
Montbeliard, France, 25209 | |
Centre Antoine Lacassagne Dpt d'Oncologie Médicale | |
Nice, France, 06189 | |
Hôpital Saint-Antoine Service d'Oncologie Médicale | |
Paris, France, 75012 | |
Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive | |
Paris, France, 75015 | |
Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive | |
Pessac, France, 33604 | |
CHU Toulouse Rangueil Oncologie médicale digestive | |
Toulouse, France, 31059 | |
Germany | |
Onkologische Schwerpunktpraxis Kurfuerstendamm | |
Berlin, Germany, 10707 | |
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei | |
Luebeck, Germany, 23562 | |
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III | |
Muenchen, Germany, 81377 | |
Hungary | |
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly | |
Budapest, Hungary, 1062 | |
Semmelweis University Radiology and Oncotherapy Clinic | |
Budapest, Hungary, 1083 | |
Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely | |
Budapest, Hungary, 1097 | |
Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia | |
Budapest, Hungary, 1115 | |
Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O. | |
Budapest, Hungary, 1122 | |
Uzsoki Utcai Korhaz Onkoradiologiai Osztaly | |
Budapest, Hungary, 1145 | |
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet | |
Debrecen, Hungary, 4032 | |
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly | |
Győr, Hungary, 9024 | |
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont | |
Kecskemét, Hungary, 6000 | |
Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly | |
Nyíregyháza, Hungary, 4400 | |
Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet | |
Pécs, Hungary, 7624 | |
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika | |
Szeged, Hungary, 6720 | |
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum | |
Szolnok, Hungary, 5004 | |
Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly | |
Szombathely, Hungary, 9700 | |
Zala Megyei Korhaz Onkologiai osztaly | |
Zalaegerszeg, Hungary, 8900 | |
Ireland | |
Bon Secours Hospital | |
Cork, Ireland, 90 | |
Cork University Hospital Department of Medical Oncology | |
Cork, Ireland, T12 DC4A | |
The Adelaide and Meath Hospital | |
Dublin, Ireland, D24 NROA | |
Italy | |
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica | |
Cagliari, Italy, 09100 | |
Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA | |
Cremona, Italy, 26100 | |
Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale | |
Napoli, Italy, 80131 | |
Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1 | |
Padova, Italy, 35128 | |
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2 | |
Pisa, Italy, 56126 | |
Ospedale San Carlo U.O. Oncologia Medica | |
Potenza, Italy, 85100 | |
Arcispedale Santa Maria Nuova Unità di Oncologia | |
Reggio Emilia, Italy, 42123 | |
Policlinico Universitario Campus Biomedico UOC di Oncologia Medica | |
Roma, Italy, 00128 | |
Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia | |
Rozzano (mi), Italy, 20089 | |
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia | |
San Giovanni Rotondo, Italy, 71013 | |
Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA | |
Vicenza, Italy, 36100 | |
Latvia | |
P. Stradins Clinical University Hospital | |
Riga, Latvia, 1002 | |
Riga East Univerity Hospital Oncology Centre of Latvia | |
Riga, Latvia, 1079 | |
Lithuania | |
Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos | |
Kaunas, Lithuania, 45434 | |
Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute | |
Kaunas, Lithuania, LT-50161 | |
Klaipeda University hospital | |
Klaipėda, Lithuania, 92288 | |
National Cancer Institute | |
Vilnius, Lithuania, LT-08660 | |
Netherlands | |
Rijnstate Oncologie | |
Arnhem, Netherlands, 6815 AD | |
Albert Schweitzer Ziekenhuis Interne Geneeskunde | |
Dordrecht, Netherlands, 3318 AT | |
Catharina Ziekenhuis Interne Gesneeskunde/Oncologie | |
Eindhoven, Netherlands, 5623 EJ | |
Ikazia Ziekenhuis Oncologie | |
Rotterdam, Netherlands, 3083 AN | |
ETZ Elisabeth Interne Geneeskunde | |
Tilburg, Netherlands, 5022 GC | |
Bernhoven Interne Geneeskunde | |
Uden, Netherlands, 5406 PT | |
Poland | |
Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej | |
Białystok, Poland, 15-027 | |
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii | |
Gdańsk, Poland, 80-952 | |
Przychodnia Lekarska "KOMED" | |
Konin, Poland, 62-500 | |
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii | |
Olsztyn, Poland, 10-228 | |
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej | |
Opole, Poland, 45-061 | |
Europejskie Centrum Zdrowia Otwock Oddzial Onkologii Klinicznej | |
Otwock, Poland, 05-400 | |
Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii | |
Poznań, Poland, 61-866 | |
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi | |
Tomaszów Mazowiecki, Poland, 97-200 | |
M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow | |
Łódź, Poland, 93-513 | |
Portugal | |
Hospital Garcia de Orta Serviço de Oncologia Médica | |
Almada, Portugal, 2805-267 | |
HOSPITAL DE BRAGA Medical Oncology Department | |
Braga, Portugal, 4710-243 | |
Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID) | |
Coimbra, Portugal, 3000-075 | |
Hospital CUF Infante Santo Oncology Department | |
Lisboa, Portugal, 1350-070 | |
H. Da Luz Serviço de Oncologia | |
Lisboa, Portugal, 1500-650 | |
Hospital Beatriz Ângelo Serviço de oncologia medic | |
Loures, Portugal, 2674-514 | |
Centro Hospitalar do Porto - Hospital de Santo Antonio Institute of Biomedical Sciences Abel Salazar | |
Porto, Portugal, 4099-001 | |
Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept. | |
Porto, Portugal, 4200-072 | |
Romania | |
Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I | |
Bucuresti, Romania, 022328 | |
Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie | |
Bucuresti, Romania, 022328 | |
Spitalul Clinic "Coltea" Sectia Oncologie Medicala | |
Bucuresti, Romania, 030171 | |
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala | |
Cluj-Napoca, Romania, 400015 | |
Centrul de Oncologie Sf Nectarie Oncology Department | |
Craiova, Romania, 200347 | |
S.C Oncolab S.R.L Sectia Oncologie Medicala | |
Craiova, Romania, 200385 | |
Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala | |
Iaşi, Romania, 700483 | |
Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala | |
Sibiu, Romania, 550245 | |
S.C ONCOMED S.R.L Departament Oncologie Medicala | |
Timişoara, Romania, 300239 | |
Russian Federation | |
Arkhangelsk Clinical Oncology Dispensary chemotherapy department | |
Arkhangel'sk, Russian Federation, 163045 | |
Clinical Oncology Dispensary No.1 Chemotherapy Department | |
Krasnodar, Russian Federation, 350040 | |
Kursk Regional Clinical Oncology Dispensary Oncology Department | |
Kursk, Russian Federation, 305524 | |
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy | |
Moscow, Russian Federation, 115478 | |
University Headache Clinic Outpatient oncology clinic | |
Moscow, Russian Federation, 121467 | |
Moscow City Oncology Hospital # 62 chemotherapy department | |
Moscow, Russian Federation, 143423 | |
Omsk Clinical Oncologic Dispensary Chemotherapy | |
Omsk, Russian Federation, 644046 | |
Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department | |
Pyatigorsk, Russian Federation, 357502 | |
Rostov Research Institute of Oncology Chemotherapy department | |
Rostov-on-Don, Russian Federation, 344037 | |
Regional Clinical Oncology Dispensary | |
Ryazan', Russian Federation, 390011 | |
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy | |
Saint Petersburg, Russian Federation, 115478 | |
National Medical Research Center of Oncology N.N. Petrova | |
Saint Petersburg, Russian Federation, 197758 | |
Saint Petersburg City Oncology Clilnic | |
Saint Petersburg, Russian Federation, 198255 | |
Multidisciplinary clinic "Reaviz" | |
Samara, Russian Federation, 443011 | |
Oncology Dispensary No.2 | |
Sochi, Russian Federation, 354057 | |
State Research Institution of Oncology of Tomsk Chemotherapy | |
Tomsk, Russian Federation, 634024 | |
SBIH of YR "Clinical oncology hospital" chemotherapy department | |
Yaroslavl, Russian Federation, 150054 | |
Slovakia | |
Narodny onkologicky ustav Oddelenie klinickej onkologie | |
Bratislava, Slovakia, 833 10 | |
Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie | |
Košice, Slovakia, 04191 | |
Nemocnica s poliklinikou Stefana Kukuru, Michalovce, a.s Oddelenie okologie a radioterapie | |
Michalovce, Slovakia, 071 01 | |
Ustredna vojenska nemocnica Ruzomberok Klinika radiacnej a klinickej onkologie | |
Ružomberok, Slovakia, 034 26 | |
Spain | |
Hospital General Universitario Alicante Servicio de Oncología | |
Alicante, Spain, 03010 | |
Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica | |
Badalona, Spain, 08916 | |
H. Valle de Hebrón Servicio de Oncología - (VHIR) | |
Barcelona, Spain, 08035 | |
Hospital de la Santa Creu I Sant Pau Oncología Medica | |
Barcelona, Spain, 08041 | |
Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica | |
Córdoba, Spain, 14004 | |
Hospital Virgen de las Nieves Unidad de Oncología Médica | |
Granada, Spain, 18014 | |
Hospital Virgen de las Nieves Unidad de Oncología Médica | |
Granada, Spain, 1814 | |
INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica | |
Hospitalet de Llobregat, Spain, 08908 | |
Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica | |
Madrid, Spain, 28007 | |
Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica | |
Madrid, Spain, 28034 | |
H. Clínico San Carlos Servicio de Oncología Médica | |
Madrid, Spain, 28040 | |
HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica | |
Madrid, Spain, 28041 | |
H. Universitario La Paz Oncología Médica | |
Madrid, Spain, 28046 | |
Hospital Universitario Marqués de Valdecilla Oncología médica | |
Santander, Spain, 39008 | |
H.Virgen Del Rocio | |
Sevilla, Spain, 41013 | |
Hospital Quirónsalud Valencia Servicio de Oncología Médica | |
Valencia, Spain, 46010 | |
Hospital Universitario Miguel Servet Servicio de Oncología | |
Zaragoza, Spain, 50009 | |
Sweden | |
Falu Lasarett Onkologmottagningen | |
Falun, Sweden, 791 82 | |
Lanssjukhuset Ryhov Onkologiska kliniken | |
Jönköping, Sweden, 551 85 | |
Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09 | |
Solna, Sweden, 171 64 | |
Norrlands Universitetssjukhus Cancercentrum Umea | |
Umeå, Sweden, 901 85 | |
Akademiska sjukhuset Onkologmottagningen | |
Uppsala, Sweden, 75185 | |
Universitetssjukhuset Orebro | |
Örebro, Sweden, 701 85 | |
Ukraine | |
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre | |
Cherkasy, Ukraine, 18009 | |
Dnipro Regional Oncology Dispensary | |
Dnipro, Ukraine, 49055 | |
MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology | |
Dnipro, Ukraine, 49102 | |
Institute of Medical Radiology of S.P. Grygoryev of AMS UKR | |
Kharkiv, Ukraine, 61024 | |
Kharkiv Regional Oncology Center | |
Kharkiv, Ukraine, 61070 | |
National Institute of Cancer Abdominal Oncology Department | |
Kyiv, Ukraine, 03022 | |
Kyiv City Clinical Oncology Centre Chemotherapy Department #2 | |
Kyiv, Ukraine, 03115 | |
Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department | |
Kyiv, Ukraine, 04107 | |
Lviv Regional Oncology Center Chemotherapy department | |
Lviv, Ukraine, 79031 | |
Odesa Regional Oncology Dispensary Day patient Department | |
Odesa, Ukraine, 65010 | |
Podillia Regional Oncology Centre Chemotherapy Department | |
Vinnytsya, Ukraine, 21029 | |
Regional Clinical Oncological Dispensary Department of Oncology | |
Zaporozhye, Ukraine, 69000 | |
United Kingdom | |
Aberdeen Royal Infirmary Oncology Department | |
Aberdeen, United Kingdom, AB25 2ZN | |
University Hospitals Bristol Bristol Haematology & Oncology Centre | |
Bristol, United Kingdom, BS2 8ED | |
St James's University Hospital | |
Leeds, United Kingdom, LS9 7TF | |
Leicester Royal Infirmary The HOPE Clinical Trials Unit | |
Leicester, United Kingdom, LE1 5WW | |
Royal Marsden Hospital Department of Medicine | |
London, United Kingdom, SW3 6JJ | |
Hammersmith Hospital Gary Weston Centre | |
London, United Kingdom, W12 0HS | |
Sarah Cannon Research Institute UK Clinical Trials | |
London, United Kingdom, W1G 6AD | |
1st Floor East Wing Medical OncologyFulham Palace RoadHammersmith | |
London, United Kingdom, W6 8RF | |
Christie Hospital NHS Foundation Trust GI & Endocrine | |
Manchester, United Kingdom, M20 4BX | |
Glan Clwyd Hospital North Wales Cancer Treatment Centre | |
Rhyl, United Kingdom, LL18 5UJ | |
Royal Marsden Hospital Department of Medicine | |
Sutton, United Kingdom, SM2 5PT |
Principal Investigator: | Thierry ANDRE, PhD | Medical Oncology departement Saint-Antoine hospital (Paris France 75012) |
Study Data/Documents: Individual Participant Data Set

Responsible Party: | Institut de Recherches Internationales Servier |
ClinicalTrials.gov Identifier: | NCT03869892 |
Other Study ID Numbers: |
CL3-95005-006 2017-004059-22 ( EudraCT Number ) U1111-1206-3198 ( Other Identifier: UTN ) |
First Posted: | March 11, 2019 Key Record Dates |
Last Update Posted: | April 15, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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:
In addition, access can be requested for all interventional clinical studies in patients:
|
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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. |
URL: | https://clinicaltrials.servier.com/ |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Metastatic Cancer Colorectal Colorectal Cancer |
Colon Rectum Metastasis |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Trifluridine Bevacizumab |
Capecitabine Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |