Randomized phase II study of valproic acid in combination with bevacizumab and oxaliplatin/fluoropyrimidine regimens in patients with

KRAS mutation anti-VEGF colorectal cancer epigenetics predictive biomarker

Journal

Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808

Informations de publication

Date de publication:
2020
Historique:
received: 27 03 2020
accepted: 04 05 2020
entrez: 28 8 2020
pubmed: 28 8 2020
medline: 28 8 2020
Statut: epublish

Résumé

Despite effective treatments, metastatic colorectal cancer (mCRC) prognosis is still poor, mostly in A randomized, open-label, two-arm, multicenter phase-II study will be performed to explore whether the addition of VPA to first line bevacizumab/oxaliplatin/fluoropyrimidine regimens (mFOLFOX-6/mOXXEL) might improve progression-free survival (PFS) in The "Revolution" study aims to improve the treatment efficacy of EudraCT: 2018-001414-15; ClinicalTrials.gov identifier: NCT04310176.

Sections du résumé

BACKGROUND BACKGROUND
Despite effective treatments, metastatic colorectal cancer (mCRC) prognosis is still poor, mostly in
METHODS/DESIGN METHODS
A randomized, open-label, two-arm, multicenter phase-II study will be performed to explore whether the addition of VPA to first line bevacizumab/oxaliplatin/fluoropyrimidine regimens (mFOLFOX-6/mOXXEL) might improve progression-free survival (PFS) in
DISCUSSION CONCLUSIONS
The "Revolution" study aims to improve the treatment efficacy of
TRIAL REGISTRATION BACKGROUND
EudraCT: 2018-001414-15; ClinicalTrials.gov identifier: NCT04310176.

Identifiants

pubmed: 32849914
doi: 10.1177/1758835920929589
pii: 10.1177_1758835920929589
pmc: PMC7425244
doi:

Banques de données

ClinicalTrials.gov
['NCT04310176']

Types de publication

Journal Article

Langues

eng

Pagination

1758835920929589

Informations de copyright

© The Author(s), 2020.

Déclaration de conflit d'intérêts

Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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Auteurs

Antonio Avallone (A)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Via M. Semmola, Napoli, 80131, Italy.

Maria Carmela Piccirillo (MC)

Clinical Trials Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Elena Di Gennaro (E)

Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Carmela Romano (C)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Filomena Calabrese (F)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Maria Serena Roca (MS)

Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Fabiana Tatangelo (F)

Pathology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Vincenza Granata (V)

Radiology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Antonio Cassata (A)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Ernesta Cavalcanti (E)

Laboratory Medicine Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Nicola Maurea (N)

Cardiology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Piera Maiolino (P)

Pharmacy Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Lucrezia Silvestro (L)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Alfonso De Stefano (A)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Francesco Giuliani (F)

Medical Oncology Department, NCI Giovanni Paolo II, Bari, Italy.

Gerardo Rosati (G)

Medical Oncology Unit, S. Carlo Hospital, Potenza, Italy.

Emiliano Tamburini (E)

Dipartimento di Oncologia e Cure Palliative, Azienda Ospedaliera Cardinale G. Panico, Tricase-Lecce, Italy.

Pasquale Aprea (P)

Vascular Access Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Valeria Vicario (V)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Anna Nappi (A)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Carlo Vitagliano (C)

Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Rossana Casaretti (R)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Alessandra Leone (A)

Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Antonella Petrillo (A)

Radiology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Gerardo Botti (G)

Pathology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Paolo Delrio (P)

Colorectal Oncological Surgery, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Francesco Izzo (F)

Hepatobiliary Surgery Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Francesco Perrone (F)

Clinical Trials Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Napoli, Italy.

Alfredo Budillon (A)

Experimental Pharmacology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Via M. Semmola, Napoli, 80131, Italy.

Classifications MeSH