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 |
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Authors: | Jean-Marc Phelip Julien Edeline Jean-Frédéric Blanc Emilie Barbier Pierre Michel Vincent Bourgeois Cindy Neuzillet David Malka Sylvain Manfredi Jérôme Desrame |
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Institution: | 1. CHUde Saint Etienne, Hôpital Nord, Saint-Priest-en-Jarez, France;2. Centre Eugène Marquis, Rennes, France;3. Hôpital Haut-Lévèque, Bordeaux, France;4. FFCD EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France;5. Normandie University, UNIROUEN, Inserm 1245, IRON Group, Department of Hepatogastroenterology, Rouen University Hospital, Rouen, France;6. Hôpital Duchenne, Boulogne sur Mer, France;7. Hôpital Henri Mondor, Créteil, France;8. Institut Gustave Roussy, Villejuif, France;9. CHU Le Bocage, EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France;10. Hôpital privé Jean Mermoz, Lyon, France |
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Abstract: | IntroductionCombination 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.AimPRODIGE38-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 methodsMain 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.ConclusionThe study is opened in France (EudraCT no.: 2015-002282-35). All the patients (188) of the phase II part are currently randomized. |
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Keywords: | Advanced biliary cancer Modified folfirinox |
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