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

January 3, 2022 updated by: UNICANCER

Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

493

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Moncton, Canada, E1C 6Z8
        • The Moncton Hospital
      • Quebec, Canada, G1R 2J6
        • CHUQ - Hôtel-Dieu de Québec
      • Sault Ste. Marie, Canada, P6B 0A8
        • Algoma District Cancer Program, Sault Area Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA - Vancouver Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • CancerCare Manitoba, St. Boniface General Hospital
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Dr Leon Richard Oncology Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • The Royal Victoria Hospital - Cancer Care Program
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Health Research Institute
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Department of Medical Oncology Health Sciences North
      • Toronto, Ontario, Canada, M5G 2C4
        • General Surgery - TGH Site, Univ. Health Network
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Hopital Notre-Dame
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University (Department of Oncology)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allain Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre, University of Saskatchewan
  • France
      • Amiens, France
        • CHU Nord
      • Angers, France
        • ICO Paul Papin
      • Bobigny, France
        • Hopital Avicenne
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France
        • CHU Côte de Nacre
      • Clichy, France
        • Hôpital Beaujon
      • Colmar, France
        • Hopital Louis Pasteur
      • Dijon, France
        • CHU de Dijon - Site Bocage
      • La Roche Sur Yon, France
        • CHD Vendée
      • Lille, France
        • Hôpital Huriez
      • Lyon, France
        • Centre Leon Berard
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Lyon, France
        • Hopital de la Croix-Rousse
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • CHU Nord
      • Marseille, France
        • CHU Timone Adulte
      • Marseille, France
        • Fondation Ambroise Paré / Hôpital Européen
      • Mont de Marsan, France
        • CH Layné
      • Montpellier, France
        • CHU De ST Eloi
      • Montpellier, France
        • CRCL Val d'Aurelle
      • Nice, France
        • Centre Antoine-Lacassagne
      • Orleans, France
        • CHR Orléans - La Source
      • Paris, France
        • Groupe Hospitalier Paris Saint Joseph
      • Paris, France
        • Groupe Hospitalier Pitie-Salpetriere
      • Perpignan, France
        • Hôpital Saint-Jean
      • Pessac, France
        • Hopital Haut-Leveque
      • Reims, France
        • Centre hospitalier de Reims
      • Rouen, France
        • CHU Rouen
      • Saint Herblain, France
        • Centre René Gauducheau
      • Strasbourg, France
        • Centre Paul Strauss
      • Tours, France
        • Hôpital Trousseau
      • Vandoeuvre Les Nancy, France
        • Centre Alexis Vautrin
      • Vandœuvre-lès-Nancy, France
        • Hôpital de Brabois-CHU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically proven pancreatic ductal adenocarcinoma. Intraductal papillary mucinous tumor of the pancreas (IPMT) with invasive components are eligible.
  2. Macroscopically complete resection (R0 or R1 resection).
  3. Patients aged from 18 to 79 years.
  4. WHO performance status 0-1.
  5. No prior radiotherapy and no previous chemotherapy.
  6. 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.
  7. Adequate hematologic function (Absolute neutrophil count ANC ≥1,500 cells/mm³, platelets ≥100 000 cells/mm³ and hemoglobin ≥10 g/L - possibly after transfusion -).
  8. Serum total bilirubin ≤1.5 times the institutional upper limit of normal.
  9. Creatinine level <130 micromol/L (14.7 mg/L).
  10. 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.
  11. Interval since surgery between 21 and 84 days.
  12. Patient information and signed informed consent.
  13. Public or private health insurance coverage.

Exclusion Criteria:

  1. Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and malignant ampulloma.
  2. Metastases (including ascites or malignant pleural effusion).
  3. Macroscopic incomplete tumor removal (R2 resection).
  4. CA 19-9 > 180 U/ml within 21 days of registration on study.
  5. No heart failure or coronary heart disease symptoms.
  6. No major comorbidity that may preclude the delivery of treatment or active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.
  7. Pre-existing neuropathy, Gilbert's disease or genotype UGT1A1 * 28 / * 28.
  8. Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea.
  9. 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.
  10. Fructose intolerance.
  11. Persons deprived of liberty or under guardianship.
  12. Psychological, familial, sociological or geographical condition potentially. hampering compliance with the study protocol and follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A 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
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
Experimental: Arm B 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival (DFS)
Time Frame: 3 YEARS
to compare disease-free survival (DFS) at 3 years between the experimental and control arms.
3 YEARS

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 36 MONTHS
36 MONTHS
Specific survival
Time Frame: 36 MONTHS
36 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Collaborators

Canadian Cancer Trials Group

Investigators

  • Principal Investigator: Thierry CONROY, PROF, Centre Alexis Vautrin-VANDOEUVRE LES NANCY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2012

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 16, 2021

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prodige 24 / Accord 24
  • NCIC CTG PA.6 (Other Identifier: NCIC)
  • 2011-002026-52 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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