Back to resultsTrial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
mFolfirinox
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma (Ductal Adenocarcinoma) focused on measuring National multicentric phase III superiority trial
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tom Baker Cancer Centre
- BCCA - Vancouver Cancer Centre
- CancerCare Manitoba, St. Boniface General Hospital
- Dr Leon Richard Oncology Centre
- The Royal Victoria Hospital - Cancer Care Program
- Juravinski Cancer centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Ottawa Health Research Institute
- Niagara Health System
- Department of Medical Oncology Health Sciences North
- General Surgery - TGH Site, Univ. Health Network
- CHUM - Hopital Notre-Dame
- McGill University (Department of Oncology)
- Centre Hospitalier Universitaire de Sherbrooke
- Allain Blair Cancer Centre
- Saskatoon Cancer Centre, University of Saskatchewan
- The Moncton Hospital
- CHUQ - Hotel-Dieu de Quebec
- Algoma District Cancer Program, Sault Area Hospital
- CHU Nord
- ICO Paul Papin
- Hôpital Avicenne
- Institut Bergonié
- CHU Côte de Nacre
- Hôpital Beaujon
- Hôpital Louis Pasteur
- CHU de Dijon - Site Bocage
- CHD Vendée
- Hôpital Huriez
- Centre Léon Bérard
- Hôpital de la Croix-Rousse
- Hôpital Privé Jean Mermoz
- CHU Nord
- CHU Timone Adulte
- Fondation Ambroise Paré / Hôpital Européen
- Institut Paoli Calmettes
- CH Layné
- CHU De ST Eloi
- CRCL Val d'Aurelle
- Centre Antoine-Lacassagne
- CHR Orléans - La Source
- Groupe Hospitalier Paris Saint Joseph
- Groupe Hospitalier Pitié-Salpêtrière
- Hôpital Saint-Jean
- Hôpital Haut-Lévêque
- Centre hospitalier de Reims
- CHU Rouen
- Centre René Gauducheau
- Centre Paul Strauss
- Hôpital Trousseau
- Centre Alexis Vautrin
- Hôpital de Brabois-CHU de Nancy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A GEMCITABINE
Arm B mFOLFIRINOX
Arm Description
Arm 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 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)
Outcomes
Primary Outcome Measures
disease-free survival (DFS)
to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
Secondary Outcome Measures
Overall survival
Specific survival
Full Information
NCT ID
NCT01526135
First Posted
February 1, 2012
Last Updated
January 3, 2022
Sponsor
UNICANCER
Collaborators
Canadian Cancer Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT01526135
Brief Title
Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
Official Title
Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2012 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
July 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Canadian Cancer Trials Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy The main criterion is the disease-free survival at 3 years. Disease-free survival is the time delay between the date of randomization and the date at which the 1st cancer-related event such as local relapse, distant metastasis, a second cancer or death from any cause is observed. Patients without event at the time of anlaysis will be censored at the date of last follow-up visit.
Locoregional relapse is a disease relapse occurring at the site of primary resection, in the pancreas or in the associated regional lymph nodes.
Metastatic relapse is the distant disease recurrence involving any possible sites of relapse (peritoneal, hepatic, pulmonary, and distant lymph nodes).
Secondary criteria Overall and specific survival Overall survival is the time delay between the date of randomization and the patient's death, irrespective of its cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.
Specific survival is the time delay between the date of randomization and the patient's death due to the treated cancer or a treatment-related complication.
Metastasis-free survival Metastasis-free survival is the time delay between the date of randomization and the date of the 1st distant event occurrence (peritoneal, hepatic, pulmonary, and lymph nodes). Loco-regional events will be discarded and patients still living without metastasis at the time of analysis will be censored at the date of last follow-up examination objectively assessing this type of event.
Tolerance Patients evaluable for toxicity must have received at least one course or injection of the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Keywords
National multicentric phase III superiority trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A GEMCITABINE
Arm Type
Active Comparator
Arm Description
Arm 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 Title
Arm B mFOLFIRINOX
Arm Type
Experimental
Arm Description
Arm 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)
Intervention Type
Drug
Intervention Name(s)
mFolfirinox
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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
Primary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
Time Frame
3 YEARS
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
36 MONTHS
Title
Specific survival
Time Frame
36 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry CONROY, PROF
Organizational Affiliation
Centre Alexis Vautrin-VANDOEUVRE LES NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba, St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Dr Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
The Royal Victoria Hospital - Cancer Care Program
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Juravinski Cancer centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Ottawa Health Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Niagara Health System
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
Department of Medical Oncology Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
General Surgery - TGH Site, Univ. Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University (Department of Oncology)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Allain Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
The Moncton Hospital
City
Moncton
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
CHUQ - Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Algoma District Cancer Program, Sault Area Hospital
City
Sault Ste. Marie
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
CHU Nord
City
Amiens
Country
France
Facility Name
ICO Paul Papin
City
Angers
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Facility Name
Hôpital Louis Pasteur
City
Colmar
Country
France
Facility Name
CHU de Dijon - Site Bocage
City
Dijon
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
Country
France
Facility Name
Hôpital Huriez
City
Lille
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
Country
France
Facility Name
CHU Nord
City
Marseille
Country
France
Facility Name
CHU Timone Adulte
City
Marseille
Country
France
Facility Name
Fondation Ambroise Paré / Hôpital Européen
City
Marseille
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
CH Layné
City
Mont de Marsan
Country
France
Facility Name
CHU De ST Eloi
City
Montpellier
Country
France
Facility Name
CRCL Val d'Aurelle
City
Montpellier
Country
France
Facility Name
Centre Antoine-Lacassagne
City
Nice
Country
France
Facility Name
CHR Orléans - La Source
City
Orleans
Country
France
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
Hôpital Saint-Jean
City
Perpignan
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac
Country
France
Facility Name
Centre hospitalier de Reims
City
Reims
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Hôpital Trousseau
City
Tours
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre Les Nancy
Country
France
Facility Name
Hôpital de Brabois-CHU de Nancy
City
Vandœuvre-lès-Nancy
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
36048453
Citation
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. Erratum In: JAMA Oncol. 2023 Jan 1;9(1):151.
Results Reference
derived
PubMed Identifier
30575490
Citation
Conroy 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.
Results Reference
derived
Learn more about this trial
Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
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