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Modified FOLFIRINOX versus CisGem first-line chemotherapy for locally advanced non resectable or metastatic biliary tract cancer (AMEBICA)-PRODIGE 38: Study protocol for a randomized controlled multicenter phase II/III study by Jean-Marc Phelip; Julien Edeline; Jean-Frédéric Blanc; Emilie Barbier; Pierre Michel; Vincent Bourgeois; Cindy Neuzillet; David Malka; Sylvain Manfredi; Jérôme Desrame is a Medicine article available to read on EtoBox.

What is Modified FOLFIRINOX versus CisGem first-line chemotherapy for locally advanced non resectable or metastatic biliary tract cancer (AMEBICA)-PRODIGE 38: Study protocol for a randomized controlled multicenter phase II/III study about?

## Introduction: Combination of cisplatine and gemcitabine (cisgem) is the reference 1st line chemotherapy in patients with advanced biliary cancer. folfirinox demonstrated an overall survival superiority when compared to gemcitabine in 1st line for patients with metastatic pancreatic adenocarcinoma. because of similarities between pancreatic and biliary cancers, we proposed a randomized trial comparing mfolfirinox and cisgem. ## Aim: Prodige38-amebica is a phase ii/iii trial evaluating efficacy of modifed folfirinox (d1 bolus removed) or cisgem on patients with locally advanced non resectable or metastatic biliary tract cancer. ## Patients and methods: Main inclusion criteria are histologically or cytologically proven biliary tract tumor (intra or extra hepatic or hilar or gallbladder carcinoma), measurable disease (metastases and/or primary tumor), bilirubin <1,5 n and transaminases <5 n. the randomization (ratio 1:1) will be stratified on center, stage of the disease, tumor localization and previous adjuvant treatment. the phase ii trial has an objective of 73% patients alive and without progression at 6 months for folfirinox (versus 59% for gemcis). 128 additional patients shou

Who reads Modified FOLFIRINOX versus CisGem first-line chemotherapy for locally advanced non resectable or metastatic biliary tract cancer (AMEBICA)-PRODIGE 38: Study protocol for a randomized controlled multicenter phase II/III study?

Author

Jean-Marc Phelip; Julien Edeline; Jean-Frédéric Blanc; Emilie Barbier; Pierre Michel; Vincent Bourgeois; Cindy Neuzillet; David Malka; Sylvain Manfredi; Jérôme Desrame

Publisher

Elsevier BV

Published

2018

Language

EN

Field

Medicine (Health Sciences)