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

Summary

This trial compares induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of pathologic complete response (pCR).

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

Sponsors & Collaborators

• Pivotal S.L.

  collaborator INDUSTRY

• Grupo Espanol Multidisciplinario del Cancer Digestivo

  lead OTHER

Principal Investigators

• Carlos Fernández-Martos, MD · Fundación Instituto Valenciano de Oncología

• Antonieta Salud Salvia, MD · Hospital Universitari Arnau de Vilanova de Lleida

• Carles Pericay Pijaume, MD · Hospital de Sabadell - Parc Taulí

• Clara Montagut, MD · Hospital del Mar

• Joan Maurel Santasusana, MD · Hospital Clinic i provincial de Barcelona

• Vicente Alonso Orduña, MD · Hospital Miguel Servet

• Ruth Vera García, MD · Complejo Hospitalario de Navarra

• Javier Gallego Plazas, MD · Hospital General Universitario de Elche

• Núria Rodríguez Salas, MD · Hospital Universitario La Paz

• Antonio Cubillo, MD · Hospital Universitario Madrid Sanchinarro (CIOCC)

• Bertomeu Massuti, MD · Hospital General Universitario de Alicante

• Ferrán Losa, MD · Hospital de Sant Joan Despí Moisés Broggi

• Miguel Nogué, MD · Hospital General de Granollers

• Jaume Capdevila, MD · Hospital Universitari Vall d'Hebrón

• Isabel Busquier, MD · Consorcio Hospitalario Provincial de Castellón

• Inma Guash Jordan, MD · Fundación Althaia Manresa

• Laura Layos Romero, MD · Hospital Universitari Germans Trias i Pujol de Badalona

• Marta Martín-Richard, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Rocio García Carbonero, MD · Hospital Universitario 12 de Octubre

• Carlos López López, MD · Hospital Universitario Marqués de Valdecilla

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2019-07-15

Completion

2020-02-04