Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma
3 other identifiers
interventional
493
2 countries
52
Brief Summary
This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2012
Longer than P75 for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedStudy Start
First participant enrolled
April 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2021
CompletedJanuary 4, 2022
January 1, 2022
5.9 years
February 1, 2012
January 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival (DFS)
to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
3 YEARS
Secondary Outcomes (2)
Overall survival
36 MONTHS
Specific survival
36 MONTHS
Study Arms (2)
Arm A GEMCITABINE
ACTIVE COMPARATORArm A : 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
Arm B mFOLFIRINOX
EXPERIMENTALArm B : mFOLFIRINOX every 14 days, 12 cycles, 24 weeks. 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)
Interventions
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)
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
Eligibility Criteria
You may qualify if:
- Histologically proven pancreatic ductal adenocarcinoma. Intraductal papillary mucinous tumor of the pancreas (IPMT) with invasive components are eligible.
- Macroscopically complete resection (R0 or R1 resection).
- Patients aged from 18 to 79 years.
- WHO performance status 0-1.
- No prior radiotherapy and no previous chemotherapy.
- Full recovery from surgery and patient able to receive chemotherapy: adequate oral nutrition of ≥1500 calories per day and free of significant nausea and vomiting.
- Adequate hematologic function (Absolute neutrophil count ANC ≥1,500 cells/mm³, platelets ≥100 000 cells/mm³ and hemoglobin ≥10 g/L - possibly after transfusion -).
- Serum total bilirubin ≤1.5 times the institutional upper limit of normal.
- Creatinine level \<130 micromol/L (14.7 mg/L).
- Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men.
- Interval since surgery between 21 and 84 days.
- Patient information and signed informed consent.
- Public or private health insurance coverage.
You may not qualify if:
- Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and malignant ampulloma.
- Metastases (including ascites or malignant pleural effusion).
- Macroscopic incomplete tumor removal (R2 resection).
- CA 19-9 \> 180 U/ml within 21 days of registration on study.
- No heart failure or coronary heart disease symptoms.
- No major comorbidity that may preclude the delivery of treatment or active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.
- Pre-existing neuropathy, Gilbert's disease or genotype UGT1A1 \* 28 / \* 28.
- Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea.
- Concomitant occurrence of another cancer, or history of cancer except in situ carcinoma of the cervix treated or basal cell carcinoma or squamous cell carcinoma.
- Fructose intolerance.
- Persons deprived of liberty or under guardianship.
- Psychological, familial, sociological or geographical condition potentially. hampering compliance with the study protocol and follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
- Canadian Cancer Trials Groupcollaborator
Study Sites (52)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba, St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Dr Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
The Royal Victoria Hospital - Cancer Care Program
Barrie, Ontario, L4M 6M2, Canada
Department of Medical Oncology Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
Juravinski Cancer centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Ottawa Health Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
General Surgery - TGH Site, Univ. Health Network
Toronto, Ontario, M5G 2C4, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University (Department of Oncology)
Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Allain Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 4H4, Canada
The Moncton Hospital
Moncton, E1C 6Z8, Canada
CHUQ - Hotel-Dieu de Quebec
Québec, G1R 2J6, Canada
Algoma District Cancer Program, Sault Area Hospital
Sault Ste. Marie, P6B 0A8, Canada
CHU Nord
Amiens, France
ICO Paul Papin
Angers, France
Hôpital Avicenne
Bobigny, France
Institut Bergonié
Bordeaux, France
CHU Côte de Nacre
Caen, France
Hôpital Beaujon
Clichy, France
Hôpital Louis Pasteur
Colmar, France
CHU de Dijon - Site Bocage
Dijon, France
CHD Vendée
La Roche-sur-Yon, France
Hôpital Huriez
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital de la Croix-Rousse
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
CHU Nord
Marseille, France
CHU Timone Adulte
Marseille, France
Fondation Ambroise Paré / Hôpital Européen
Marseille, France
Institut Paoli Calmettes
Marseille, France
CH Layné
Mont-de-Marsan, France
CHU De ST Eloi
Montpellier, France
CRCL Val d'Aurelle
Montpellier, France
Centre Antoine-Lacassagne
Nice, France
CHR Orléans - La Source
Orléans, France
Groupe Hospitalier Paris Saint Joseph
Paris, France
Groupe Hospitalier Pitié-Salpêtrière
Paris, France
Hôpital Saint-Jean
Perpignan, France
Hôpital Haut-Lévêque
Pessac, France
Centre hospitalier de Reims
Reims, France
CHU Rouen
Rouen, France
Centre René Gauducheau
Saint-Herblain, France
Centre Paul Strauss
Strasbourg, France
Hôpital Trousseau
Tours, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Hôpital de Brabois-CHU de Nancy
Vandœuvre-lès-Nancy, France
Related Publications (2)
Conroy T, Castan F, Lopez A, Turpin A, Ben Abdelghani M, Wei AC, Mitry E, Biagi JJ, Evesque L, Artru P, Lecomte T, Assenat E, Bauguion L, Ychou M, Bouche O, Monard L, Lambert A, Hammel P; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Nov 1;8(11):1571-1578. doi: 10.1001/jamaoncol.2022.3829.
PMID: 36048453DERIVEDConroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
PMID: 30575490DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry CONROY, PROF
Centre Alexis Vautrin-VANDOEUVRE LES NANCY
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 3, 2012
Study Start
April 16, 2012
Primary Completion
March 1, 2018
Study Completion
July 16, 2021
Last Updated
January 4, 2022
Record last verified: 2022-01