Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

July 15, 2019

Study Completion Date

February 4, 2020

Conditions
Rectal Cancer
Interventions
DRUG

Aflibercept

Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml

DRUG

5-Fluoruracil

Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2

DRUG

Oxaliplatin

Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU

DRUG

Leucovorin

Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU

All Listed Sponsors
collaborator

Pivotal S.L.

INDUSTRY

lead

Grupo Espanol Multidisciplinario del Cancer Digestivo

OTHER

NCT02340949 - Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter