Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

December 15, 2015

Primary Completion Date

June 27, 2018

Study Completion Date

January 16, 2020

Conditions
Bile Duct Cancer
Interventions
DRUG

GEMCIS

"At D1 and D8 of each cycle, i.e. every 21 days for 6 months:~* Cisplatin 25 mg/m² over 1 hour at D1 and D8~* Gemcitabine 1000 mg/m² over 30 minutes at D1 and D8."

DRUG

mFolfirinox

"At D1 of each cycle, i.e. every 15 days for 6 months:~* Oxiplatin: 85 mg/m² (IP/120 minutes)~* Irinotecan: 180 mg/m² (IV/90 minutes)~* Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine \[calcium levofolinate\]) (IV/2 hours), via a Y connector at the same time as irinotecan~* 5-FU: 2400 mg/m² (IV over 46 hours) without 5FU bolus at D1"

Trial Locations (42)

21000

Centre de radiothérapie et oncologie du Parc, Dijon

33000

Hôpital Saint-André, Bordeaux

Polyclinique Nord, Bordeaux

42055

CHU Saint-Etienne, Saint-Etienne

64109

CH de la Côte Basque, Bayonne

64500

CH Saint-Jean de Luz, Saint-Jean-de-Luz

67065

CAC Paul Strauss, Strasbourg

69000

Clinique de la Sauvegarde, Lyon

91100

Ch Sud Francilien, Corbeil-Essonnes

91160

Centre Hospitalier de Longjumeau, Longjumeau

Unknown

Chu Picardie, Amiens

Ico Paul Papin, Angers

CH Victor Dupouy, Argenteuil

CHRU Besançon, Besançon

Hôpital Avicenne, Bobigny

Hôpital Duchenne, Boulogne-sur-Mer

Centre François Baclesse, Caen

Chu D'Estaing, Clermont-Ferrand

Hôpitaux Civils, Colmar

Centre Georges François Leclerc, Dijon

Hôpital Michallon, Grenoble

CHD Vendée, La Roche-sur-Yon

Clinique du cap d'Or, La Seyne-sur-Mer

CH Le Kremlin Bicetre, Le Kremlin-Bicêtre

CHRU Lille, Lille

Centre Léon Bérard, Lyon

Hôpital de la Croix Rousse, Lyon

Hôpital Lyon Sud, Lyon

Hôpital Saint-Joseph, Marseille

Centre Catherine de Sienne, Nantes

CHR Orléans, Orléans

HEGP, Paris

Hôpital Cochin, Paris

Hôpital Saint-Jean, Perpignan

CHU La Miletrie, Poitiers

CHU Reims, Reims

Centre Eugène Marquis, Rennes

Hôpital Drôme Nord, Romans-sur-Isère

Chu Rouen, Rouen

CH Saint-Quentin, Saint-Quentin

Ch Robert Morlevat, Semur-en-Auxois

CHU Tours, Tours

All Listed Sponsors
collaborator

Federation Francophone de Cancerologie Digestive

OTHER

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT02591030 - Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours | Biotech Hunter | Biotech Hunter