A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

December 18, 2018

Primary Completion Date

November 18, 2022

Study Completion Date

November 18, 2022

Conditions
Colo-rectal Cancer
Interventions
DRUG

Arfolitixorin

Bevacizumab 5 mg/kg intravenous infusion; Oxaliplatin 85 mg/m2 intravenous infusion; 5-FU 400 mg/m2 intravenous bolus; Arfolitixorin 60 mg/m2 intravenous bolus; 5-FU 2400 mg/m2 intravenous infusion; Arfolitixorin 60 mg/m2 intravenous bolus

DRUG

Leucovorin

Bevacizumab 5 mg/kg intravenous infusion; Oxaliplatin 85 mg/m2 intravenous infusion; Leucovorin 400 mg/m2 intravenous infusion; 5-FU 400 mg/m2 intravenous infusion; 5-FU 2400 mg/m2 intravenous infusion

Trial Locations (94)

1090

040-01 - Allgemeines Krankenhaus der Stadt Wien, Vienna

1160

040-05 - Wilhelminenspital, Vienna

2050

036-02 - Chris O'Brien Lifehouse, Sydney

2145

036-03 - Westmead Hospital, Sydney

2500

036-09 - Southern Medical Day Care Center, Wollongong

2640

036-10 - Border Medical Oncology Research Unit, Albury

2700

040-04 - Landesklinikum Wiener Neustadt, Wiener Neustadt

3021

036-01 - Western Health - Sunshine Hospital, Melbourne

3076

036-07 - Northern Health - Epping Hospital, Melbourne

3168

036-05 - Monash Health, Melbourne

3199

036-04 - Peninsula Health - Frankston Hospital, Frankston

4010

040-06 - Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz

5020

040-03 - Uniklinikum Salzburg, Salzburg

9020

040-02 - Klinikum Klagenfurt am Wörthersee, Klagenfurt

10117

276-12 - Charité - Universitätsmedizin Berlin, Berlin

11525

300-04 - 251 Airforce Hospital, Athens

11528

300-01 - Aretaieo Hospital, Athens

13003

250-08 - Hôpital Européen, Marseille

14004

724-06 - Hospital Universitario Reina Sofia, Córdoba

15562

300-02 - University General Hospital Attikon, Athens

300-03 - Metropolitan General Hospital, Athens

300-05 - Metropolitan General SA, Athens

20246

276-10 - Universitärers Cancer Center Hamburg (UCCH), Hamburg

21000

250-06 - Centre Georges Francois Leclerc, Dijon

24000

250-04 - Polyclinique Francheville, Périgueux

28041

724-04 - Hospital Unviersitario 12 de Octubre, Madrid

28050

724-09 - Hospital Universitario HM Sanchinarro, Madrid

29010

724-02 - Hospital Regional Universitario Carlos Haya, Málaga

29414

840-27 - Charleston Hematology Oncology Associates, Charleston

33136

840-32 - University of Miami, Miami

33709

840-08 - Pinellas Hematology Oncology, St. Petersburg

34125

276-11 - Klinikum Kassel GmbH, Kassel

35032

276-07 - Philipps-Universität Marburg, Marburg

41013

724-05 - Hospital Universitario Virgen del Rocío, Seville

41101

840-29 - Ashland-Bellefonte Cancer Center, Ashland

41110

300-06 - University General Hospital of Larissa, Larissa

48109

840-14 - University of Michigan Cancer Center, Ann Arbor

59102

840-04 - St. Vincent Frontier Cancer Center, Billings

60435

840-30 - Joliet Oncology-Hematology Associates, Joliet

60488

276-03 - Krankenhaus Nordwest GmbH, Frankfurt am Main

67000

250-05 - Clinique Sainte Anne, Strasbourg

67214

840-06 - Cancer Center of Kansas, Wichita

69373

250-09 - Hopital Privé Jean Mermoz, Lyon

73104

840-22 - University of Oklahoma Stephenson Cancer Center, Oklahoma City

75014

250-03 - Hôpital Paris Saint Joseph, Paris

75571

250-02 - Hôpital Saint-Antoine, Paris

78229

840-02 - The University of Texas Health Science Center, San Antonio

80631

840-34 - Banner MD Anderson Cancer Center, Greeley

80909

840-13 - UCH-MHS d/b/a Memorial Health System, Colorado Springs

81377

276-01 - Klinikum der Universität München - Campus Grosshadern, München

85234

840-24 - Banner Gateway Medical Center, Gilbert

90419

276-09 - Klinikum Nürnberg Nord, Nuremberg

91001

840-15 - University of Southern California, Los Angeles

92300

250-01 - Institute Hospitalier Franco-Britannique, Levallois-Perret

92637

276-05 - Kliniken Nordoberpfalz AG, Weiden

92663

840-01 - HOAG Memorial Hospital, Newport Beach

94010

250-07 - Hôpital Henri Mondor, Créteil

97239

840-10 - Oregon Health and Science University-Knight Cancer Institute, Portland

40202-1798

840-19 - University of Louisville Research Foundation Inc. (ULRF), Louisville

08903

840-12 - Rutgers Cancer Institute of New Jersey, New Brunswick

L6R 3J7

124-03 - William Osler Health System - Brampton Civi Hospital, Brampton

P7B 6V4

124-10 - Thunder Bay Regional Health Research Institute, Thunder Bay

M4N 3M5

124-07 - Sunnybrook Research Institute, Toronto

J8V 2L4

124-04 - CISSS de l'Outaouais - Hôpital de Gatineau, Gatineau

G6V 3Z1

124-11 - CISSS de Chaudière-Appalaches, Lévis

H4A 3J1

124-01 - Montreal University Health Center, Montreal

H7M 3L9

124-02 - Hôpital de la Cité-de-la-Santé, Laval

H1T 2M4

124-08 - Hôpital Maisonneuve Rosemont, Montreal

H3T 1E2

124-06 - Jewish General Hospital, Montreal

KIH8L6

124-05 - Ottawa Hospital Research Institute, Ottawa

01307

276-02 - Universitätsklinikum Carl Gustav Carus, Dresden

04103

276-04 - MVZ Mitte - Onkologische Schwerpunktpraxis, Leipzig

276-13 - Universitäres Krebszentrum Leipzig (UCCL), Leipzig

06217

276-08 - Carl von Basedow Klinikum Saalekrei GmbH, Merseburg

464-8681

392-10 - Aichi Cancer Center, Aichi

277-8577

392-01 - National Cancer Center Hospital East, Chiba

791-0280

392-09 - National Hospital Organization Shikoku Cancer Center, Ehime

501-1194

392-07 - Gifu University Hospital, Gifu

350-1298

392-12 - Saitama Medical University International Medical Center, Hidaka

305-8576

392-05 - University of Tsukuba Hospital, Ibaraki

761-0793

392-15 - Kagawa University Hospital, Kagawa

216-8511

392-08 - St.Marianna University School of Medicine Hospital, Kanagawa

540-0006

392-11 - National Hospital Organization Osaka National Hospital, Osaka

558-8558

392-13 - Osaka General Medical Center, Osaka

573-1191

392-14 - Kansai Medical University Hospital, Osaka

362-0806

392-04 - Saitama Cancer Center, Saitama

060-8648

392-03 - Hokkaido University Hospital, Sapporo Hokkaido

411-8777

392-02 - Shizuoka Cancer Center, Shizuoka

104-0045

392-06 - National Cancer Center Hospital, Tokyo

08023

724-03 - Instituto Oncologico Baselga - Hospital Quiron, Barcelona

08026

724-07 - Hospital del la Santa Creu i Sant Pau, Barcelona

08035

724-01 - Vall d'Hebron Institute of Oncology, Barcelona

118 83

752-02 - Södersjukhuset, Stockholm

751 85

752-01 - Akademiska Sjukhuset, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Isofol Medical AB

INDUSTRY