Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma
- Conditions
- Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
- Interventions
- Drug: mFolfirinox
- Registration Number
- NCT01526135
- Lead Sponsor
- UNICANCER
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B mFOLFIRINOX mFolfirinox 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) Arm A GEMCITABINE Gemcitabine 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
- Primary Outcome Measures
Name Time Method disease-free survival (DFS) 3 YEARS to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
- Secondary Outcome Measures
Name Time Method Overall survival 36 MONTHS Specific survival 36 MONTHS
Trial Locations
- Locations (51)
CH Layné
🇫🇷Mont de Marsan, France
Dr Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
CHU De ST Eloi
🇫🇷Montpellier, France
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
The Moncton Hospital
🇨🇦Moncton, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Hôpital Beaujon
🇫🇷Clichy, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
Institut Bergonié
🇫🇷Bordeaux, France
CHD Vendée
🇫🇷La Roche Sur Yon, France
CHU de Dijon - Site Bocage
🇫🇷Dijon, France
ICO Paul Papin
🇫🇷Angers, France
CHU Côte de Nacre
🇫🇷Caen, France
Hôpital Louis Pasteur
🇫🇷Colmar, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital Huriez
🇫🇷Lille, France
Centre Antoine-Lacassagne
🇫🇷Nice, France
Hôpital Saint-Jean
🇫🇷Perpignan, France
Centre Léon Bérard
🇫🇷Lyon, France
Centre René Gauducheau
🇫🇷Saint Herblain, France
Saskatoon Cancer Centre, University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Allain Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Juravinski Cancer centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
Ottawa Health Research Institute
🇨🇦Ottawa, Ontario, Canada
Department of Medical Oncology Health Sciences North
🇨🇦Sudbury, Ontario, Canada
General Surgery - TGH Site, Univ. Health Network
🇨🇦Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Algoma District Cancer Program, Sault Area Hospital
🇨🇦Sault Ste. Marie, Canada
McGill University (Department of Oncology)
🇨🇦Montreal, Quebec, Canada
CHUQ - Hotel-Dieu de Quebec
🇨🇦Quebec, Canada
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, France
Fondation Ambroise Paré / Hôpital Européen
🇫🇷Marseille, France
Groupe Hospitalier Pitié-Salpêtrière
🇫🇷Paris, France
CRCL Val d'Aurelle
🇫🇷Montpellier, France
CHU Rouen
🇫🇷Rouen, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Hôpital de Brabois-CHU de Nancy
🇫🇷Vandœuvre-lès-Nancy, France
Hôpital Trousseau
🇫🇷Tours, France
CancerCare Manitoba, St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
CHU Nord
🇫🇷Marseille, France
CHU Timone Adulte
🇫🇷Marseille, France
CHR Orléans - La Source
🇫🇷Orleans, France
Centre hospitalier de Reims
🇫🇷Reims, France
Hôpital Haut-Lévêque
🇫🇷Pessac, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre Les Nancy, France
The Royal Victoria Hospital - Cancer Care Program
🇨🇦Barrie, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada