Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

April 16, 2012

Primary Completion Date

March 31, 2018

Study Completion Date

July 16, 2021

Conditions
Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Interventions
DRUG

mFolfirinox

"mFolfirinox every 14 days, 12 cycles, 24 weeks.~mFolfirinox : Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started.~Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours.~5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day)"

DRUG

Gemcitabine

Gemcitabine 1000 mg/m² IV infusion over 30 minutes, weekly, during 3 weeks + 1 week of rest (= 1 cycle) repeated 6 times (i.e., 6 cycles) during 24 weeks

Trial Locations (52)

T2N 4N2

Tom Baker Cancer Centre, Calgary

V5Z 4E6

BCCA - Vancouver Cancer Centre, Vancouver

R2H 2A6

CancerCare Manitoba, St. Boniface General Hospital, Winnipeg

E1C 8X3

Dr Leon Richard Oncology Centre, Moncton

L4M 6M2

The Royal Victoria Hospital - Cancer Care Program, Barrie

P3E 5J1

Department of Medical Oncology Health Sciences North, Greater Sudbury

L8V 5C2

Juravinski Cancer centre at Hamilton Health Sciences, Hamilton

K7L 5P9

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

K1H 8L6

Ottawa Health Research Institute, Ottawa

L2S 0A9

Niagara Health System, St. Catharines

M5G 2C4

General Surgery - TGH Site, Univ. Health Network, Toronto

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H2W 1S6

McGill University (Department of Oncology), Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

S4T 7T1

Allain Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, University of Saskatchewan, Saskatoon

E1C 6Z8

The Moncton Hospital, Moncton

G1R 2J6

CHUQ - Hotel-Dieu de Quebec, Québec

P6B 0A8

Algoma District Cancer Program, Sault Area Hospital, Sault Ste. Marie

Unknown

CHU Nord, Amiens

ICO Paul Papin, Angers

Hôpital Avicenne, Bobigny

Institut Bergonié, Bordeaux

CHU Côte de Nacre, Caen

Hôpital Beaujon, Clichy

Hôpital Louis Pasteur, Colmar

CHU de Dijon - Site Bocage, Dijon

CHD Vendée, La Roche-sur-Yon

Hôpital Huriez, Lille

Centre Léon Bérard, Lyon

Hôpital de la Croix-Rousse, Lyon

Hôpital Privé Jean Mermoz, Lyon

CHU Nord, Marseille

CHU Timone Adulte, Marseille

Fondation Ambroise Paré / Hôpital Européen, Marseille

Institut Paoli Calmettes, Marseille

CH Layné, Mont-de-Marsan

CHU De ST Eloi, Montpellier

CRCL Val d'Aurelle, Montpellier

Centre Antoine-Lacassagne, Nice

CHR Orléans - La Source, Orléans

Groupe Hospitalier Paris Saint Joseph, Paris

Groupe Hospitalier Pitié-Salpêtrière, Paris

Hôpital Saint-Jean, Perpignan

Hôpital Haut-Lévêque, Pessac

Centre hospitalier de Reims, Reims

CHU Rouen, Rouen

Centre René Gauducheau, Saint-Herblain

Centre Paul Strauss, Strasbourg

Hôpital Trousseau, Tours

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

Hôpital de Brabois-CHU de Nancy, Vandœuvre-lès-Nancy

All Listed Sponsors
collaborator

Canadian Cancer Trials Group

NETWORK

lead

UNICANCER

OTHER

NCT01526135 - Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma | Biotech Hunter | Biotech Hunter