Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

492

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

July 19, 2022

Study Completion Date

September 12, 2023

Conditions
Refractory Metastatic Colorectal Cancer
Interventions
DRUG

Trifluridine/Tipiracil

Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest

DRUG

Bevacizumab

administered every 2 weeks (Day 1 and Day 15)

Trial Locations (99)

1062

Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly, Budapest

1090

"Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie", Vienna

1115

Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly, Budapest

2100

Rigshospitalet Dpt of Oncology, Copenhagen

2650

"Universitair Ziekenhuis Antwerpen Oncologie", Edegem

2700

"Landesklinikum Wiener Neustadt ", Wiener Neustadt

3000

"UZ Leuven Campus Gasthuisberg Digestieve Oncologie", Leuven

4000

"CHC Montlégia Oncologie", Liège

4010

"Ordensklinikum Linz Barmherzige Schwestern Interne I", Linz

4032

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet, Debrecen

5000

"Odense Universitetshospital Department of Oncology", Odense

5004

JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum, Szolnok

5020

"Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)", Salzburg

6000

Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont, Kecskemét

6020

"Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V", Innsbruck

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika, Szeged

6830

"Landeskrankenhaus Feldkirch Interne E", Rankweil

7400

"Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling", Herning

8036

"Medizinische Universität Graz ", Graz

9000

"Aalborg Universitetshospital, Syd Onkologisk Afdeling", Aalborg

9024

Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly, Győr

9100

"AZ NIKOLAAS Oncology", Sint-Niklaas

Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato, Cagliari

9300

"OLV Ziekenhuis Oncology", Aalst

9700

Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly, Szombathely

10707

Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin

13353

Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie, Berlin

14004

"Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica", Córdoba

14076

"Centre de lutte contre le cancer Francois Baclesse UCP Digestif", Caen

18009

Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre, Cherkassy

20089

Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,, Rozzano (MI)

21029

Podillia Regional Oncology Centre Chemotherapy Department, Vinnitsya

23562

Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei, Lübeck

25011

"LLC Ukrainian Center of Tomotherapy Tomoclinic, Chemoteraphy Department", Kropyvnytskyi

25030

"CHU Jean Minjoz Service d'oncologie médicale", Besançon

28034

"Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica", Madrid

28041

"HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica", Madrid

29200

"CHU Morvan Institut de Cancérologie et d'Hématologie", Brest

32224

Mayo Clinic - FL, Jacksonville

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33709

Comprehensive Hematology Oncology, St. Petersburg

35128

Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64, Padua

39008

"Hospital Universitario Marqués de Valdecilla oncología medica", Santander

41013

H.VIRGEN DEL ROCIO Servicio de Oncología Médica, Seville

42123

Arcispedale Santa Maria Nuova Unità di Oncologia, Reggio Emilia

46014

H. GENERAL DE VALENCIA Servicio de Oncología Médica, Valencia

46062

Investigative Clinical Research of Indiana LLC, Noblesville

49102

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

50009

Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical, Zaragoza

55905

Mayo Clinic - Rochester, Rochester

56126

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

60435

DuPage Medical Group - Joliet Oncology-Hematology Associates, Joliet

68130

Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha

71013

IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1, San Giovanni Rotondo

75012

Hôpital Saint-Antoine Service d'Oncologie Médicale, Paris

75015

"Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive", Paris

79915

Renovatio Clinical - El Paso, El Paso

80131

"A.O.U. Seconda Universita degli Studi di Napoli U.O.C di Oncologia Medica e di Ematologia Dipartimento Medico di Internistica clinca e sperimentale F Magrassi - A. Lanzara Via Sergio Pansisni ,", Napoli

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

81377

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

85054

Mayo Clinic Hospital, Phoenix

85100

Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana, Potenza

86021

CHU de Poitiers Pole Régional de Cancérologie, Poitiers

91010

City of Hope, Duarte

91030

City of Hope - South Pasedena, South Pasadena

91786

City of Hope - Upland, Upland

115478

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

Scientific Centre for Specialized Medical Care (oncological) Chemotherapy, Saint Petersburg

121467

University Headache Clinic Outpatient oncology clinic, Moscow

143423

Moscow City Oncology Hospital # 62 chemotherapy department, Moscow Region

150054

"SBIH of YR Clinical oncology hospital chemotherapy department", Yaroslavl

163045

Arkhangelsk Clinical Oncology Dispensary chemotherapy department, Arkhangelsk

197758

National Medical Research Center of Oncology N.N. Petrova, Saint Petersburg

198255

Saint Petersburg City Oncology Clilnic, Saint Petersburg

350040

Clinical Oncology Dispensary No.1 Chemotherapy Department, Krasnodar

354057

Oncology dispensary No.2 Oncology department, Sochi

443011

"Multidisciplinary clinic Reaviz", Samara

644046

Omsk Clinical Oncologic Dispensary Chemotherapy, Omsk

14784-400

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

15090-000

"Hospital de Base Centro Integrado de Pesquisa", São José do Rio Preto

01246-000

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

01509-900

Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente, São Paulo

03102-002

Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado, São Paulo

05652- 900

Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein, São Paulo

62-500

"Przychodnia Lekarska KOMED", Konin

31-531

SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii, Krakow

45-061

Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej, Opole

76-200

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Słupsk

02-034

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii, Warsaw

04-141

Wojskowy Instytut Medyczny Klinika Onkologii, Warsaw

02-507

Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii, Warzszawa

00935

Pan American Center for Oncology Trials, LLC, Río Piedras

08035

"H. Valle de Hebrón Servicio de Oncología - (VHIR)", Barcelona

08041

"Hospital de la Santa Creu I Sant Pau Oncología Medica", Barcelona

08908

"INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica", L'Hospitalet de Llobregat

03115

Kyiv City Clinical Oncological Centre, Kiev

03022

National Institute of Cancer Abdominal Oncology Department, Kyiv

08112

"Medical Center n.a. Acad. Spizhenko Syber Clinic Spizhenko Department of Oncology", Kyiv

08720

"Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology LISOD", Kyiv

All Listed Sponsors
collaborator

Institut de Recherches Internationales Servier

OTHER

lead

Taiho Oncology, Inc.

INDUSTRY