Induction Therapy With Panitumumab + mFOLFOX-6 in Rectal Cancer and Quadruple Wild-type Mutation Before Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 30, 2017

Primary Completion Date

October 31, 2020

Study Completion Date

December 15, 2021

Conditions
Rectal Cancer
Interventions
DRUG

Panitumumab

Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.

DRUG

5Fluorouracil

Once every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².

DRUG

Oxaliplatin

Once every 14 days. Day 1: 85 mg/m2 I.V. infusión 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

Trial Locations (11)

3203

Hospital General Universitario de Elche, Elche

28046

Hospital Universitario La Paz, Madrid

31008

Complejo Hospitalario de Navarra, Pamplona

41013

Hospital Universitario Virgen del Rocío, Seville

46009

Fundación Instituto Valenciano de Oncología, Valencia

46014

Consorcio Hospital General Universitario de Valencia, Valencia

08208

Hospital de Sabadell, Sabadell

08970

Hospital de Sant Joan Despí Moisés Broggi, Sant Joan Despí

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall d'Hebrón, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pivotal S.L.

INDUSTRY

collaborator

Amgen

INDUSTRY

lead

Grupo Espanol Multidisciplinario del Cancer Digestivo

OTHER