Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

September 28, 2018

Primary Completion Date

February 1, 2024

Study Completion Date

February 1, 2024

Conditions
Colorectal Cancer
Interventions
DRUG

Aflibercept + mLV5FU2

Patients receive aflibercept 4mg/kg as 1-h infusion followed by folinic acid 350 mg/m² by 2-h intravenous infusion, 5-fluorouracil 1920 mg/m² 46-h intravenous infusion (mLV5FU2) every 2 weeks (qd15).

DRUG

mFOLFOX7

Patients in this arm receive modified (m) FOLFOX 7: Folinic acid 350 mg/m² and oxaliplatin 68 mg/m² by concurrent 2-h intravenous infusion, 5-FU 1920 mg/m² 46-h intravenous infusion every 2 weeks (qd15).

Trial Locations (25)

13347

MVZ Seestrasse, Berlin

15526

HELIOS Klinikum Bad Saarow, Bad Saarow

26389

Klinikum Wilhelmshaven, Wilhelmshaven

28755

Klinikum Bremen Nord, Bremen

34121

DRK-Kliniken Nordhessen gGmbH, Kassel

39130

Klinikum Magdeburg gGmbH, Magdeburg

45136

Kliniken Essen-Mitte, Essen

52222

Clinical Research Stolberg GmbH, Stolberg

54290

Klinikum Mutterhaus Trier, Trier

60431

Agaplesion Markus Krankenhaus, Frankfurt

60488

Krankenhaus Nordwest GmbH, Frankfurt

63739

Phase Drei, Aschaffenburg

66822

Onkologisches Zentrum, Lebach

67063

Klinikum Ludwigshafen, Ludwigshafen

68167

Tagestherapiezentrum am ITM Universitätsmedizin Mannheim, Mannheim

69120

Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg

72076

Universitätsklinikum Tübingen, Tübingen

73557

Kliniken Ostalb, Mutlangen

76133

Städtisches Klinikum Karlsruhe, Karlsruhe

77933

Ortenau Klinikum Lahr, Lahr

81377

Klinikum der Universität München-Großhadern, München

82467

Klinikum Garmisch-Partenkirchen GmbH, Garmisch-Partenkirchen

88212

Studienzentrum Onkologie Ravensburg, Ravensburg

92318

Kliniken des Landkreises Neumarkt in der Oberpfalz, Neumarkt in der Oberpfalz

95445

Klinikum Bayreuth, Bayreuth

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

STABIL - Statistische und Biometrische Lösungen

UNKNOWN

collaborator

Trium Analysis Online GmbH

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

NCT03530267 - Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer | Biotech Hunter | Biotech Hunter