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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

Jean-Marc Phélip 1, * Julien Edeline 2 Jean-Frédéric Blanc 3 Emilie Barbier 4, 5, 6 Pierre Michel 7, 8 Vincent Bourgeois 9 Cindy Neuzillet 10 David Malka 11 Sylvain Manfredi 12, 5, 6 Jérôme Desramé 13 - Prodige 38 Investigators
* Auteur correspondant
1 CHU de Saint-Etienne - Centre Hospitalier Universitaire de Saint-Etienne
2 CRLCC - Centre Eugène Marquis
3 Hôpital Haut-Lévêque [CHU Bordeaux]
4 Fédération Francophone de la Cancérologie Digestive, FFCD
5 Equipe EPICAD (LNC - U1231)
LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
6 UBFC - Université Bourgogne Franche-Comté [COMUE]
7 Service d'Hépato-Gastroentérologie [CHU Rouen]
8 GPMCND - Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques
9 Hôpital Duchenne
10 Hôpital Henri Mondor
11 Oncologie digestive
Département de médecine oncologique [Gustave Roussy]
12 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
13 Hôpital privé Jean Mermoz
Abstract : 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 should be added in the phase III trial with an objective of overall survival improvement of 4 months in favor of mFOLFIRINOX. Conclusion The study is opened in France (EudraCT no.: 2015-002282-35). All the patients (188) of the phase II part are currently randomized.
Keywords : Advanced biliary cancer Modified folfirinox
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-01980019
Contributeur : Lnc - Université de Bourgogne <>
Soumis le : lundi 14 janvier 2019 - 10:19:55
Dernière modification le : mercredi 1 avril 2020 - 11:02:03

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UNIV-BOURGOGNE | FNCLCC | IGR | UPEC-UPEM | LNC-UMR866 | LNC-EPICAD | COMUE-NORMANDIE | UNIROUEN | UNIV-PARIS-SACLAY | NUMECAN | UR1-UFR-SVE | UPEC | GPMCND

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Jean-Marc Phélip, Julien Edeline, Jean-Frédéric Blanc, Emilie Barbier, Pierre Michel, et al.. 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. Digestive and Liver Disease, WB Saunders, 2019, 51 (2), pp.318-320. ⟨10.1016/j.dld.2018.11.018⟩. ⟨hal-01980019⟩

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