mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

March 6, 2017

Primary Completion Date

January 11, 2021

Study Completion Date

June 1, 2022

Conditions
Rectal CancerRectosigmoid Cancer
Interventions
DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2, as 2h infusion on Day 1 (Arm A + Arm B)

DRUG

5-FU

5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusion q2w (Arm A + Arm B)

DRUG

Leucovorin

Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 (Arm A + Arm B)

BIOLOGICAL

Aflibercept

Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (Arm B, Cycles 1 to 5)

Trial Locations (1)

68167

Tagestherapiezentrum am ITM & III. Med. Klinik, Mannheim

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Institut für Klinisch-Onkologische Forschung (IKF) Frankfurt

UNKNOWN

collaborator

Sanofi

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER