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

Phase 2 Completed 180 enrolled Grupo Espanol Multidisciplinario del Cancer Digestivo Pivotal S.L. · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2015-01
Primary completion: 2019-07-15
Completion: 2020-02-04

Publications

Fernandez-Martos C, Pericay C, Losa F, Garcia-Carbonero R, Layos L, Rodriguez-Salas N, Martin-Richard M, Alonso-Orduna V, Vera R, Gallego J, Capdevila J, Salud A, Nogue M, Maurel J, Guash I, Montagut C, Lopez C, Macias I, Jain RK, Garcia-Albeniz X. Effect of Aflibercept Plus Modified FOLFOX6 Induction Chemotherapy Before Standard Chemoradiotherapy and Surgery in Patients With High-Risk Rectal Adenocarcinoma: The GEMCAD 1402 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1566-1573. doi: 10.1001/jamaoncol.2019.2294.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	4 mg/kg	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications