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Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)Phase 3NCT01526135

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

A Phase 3 study testing mFolfirinox and Gemcitabine in people with Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), run by UNICANCER at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
mFolfirinox and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
52 sitesin 2 countries
Study dates
16 Apr 2012to 16 Jul 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

France33 sites

  • 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

Other trials in France

Canada19 sites

  • The Royal Victoria Hospital - Cancer Care Program

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Department of Medical Oncology Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Juravinski Cancer centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Dr Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • The Moncton Hospital

    Moncton, E1C 6Z8

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University (Department of Oncology)

    Montreal, Quebec, H2W 1S6

  • Ottawa Health Research Institute

    Ottawa, Ontario, K1H 8L6

  • CHUQ - Hotel-Dieu de Quebec

    Québec, G1R 2J6

  • Allain Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre, University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Cancer Program, Sault Area Hospital

    Sault Ste. Marie, P6B 0A8

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

  • General Surgery - TGH Site, Univ. Health Network

    Toronto, Ontario, M5G 2C4

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba, St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
mFolfirinox, Gemcitabine
Keywords
National multicentric phase III superiority trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mFolfirinoxDrug

    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)

  • GemcitabineDrug

    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

Study groups in NCT01526135
Study groupRoleWhat they receive
Arm A GEMCITABINEActive 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
Receives: Drug: Gemcitabine
Arm B mFOLFIRINOXExperimentalArm 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)
Receives: Drug: mFolfirinox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease-free survival (DFS)

    to compare disease-free survival (DFS) at 3 years between the experimental and control arms.

    Measured: 3 YEARS

Secondary outcomes (2)

  1. Overall survival

    Measured: 36 MONTHS

  2. Specific survival

    Measured: 36 MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2012 (estimated)
  2. Study start16 Apr 2012
  3. Primary completionMar 2018
  4. Study completion16 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01526135
Sponsor's protocol ID
Prodige 24 / Accord 24
Other IDs
NCIC CTG PA.6, 2011-002026-52
Status last verified
Jan 2022
First submitted
1 Feb 2012
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Witz A, Conroy T, Lambert A, Salleron J, Diallo A, Husson M, Nicolle R, Hammel P, Biagi J, Renouf DJ, Turpin A, Richard C, Bachet JB, Iovanna J, Dusetti N, Monard L, Mauduit M, Cros J, Harle A. Impact of Tumor Genomic Profile on Adjuvant Chemotherapy Efficacy in Resected Pancreatic Adenocarcinoma: Results From the PRODIGE-24/CCTG PA6 Study. J Clin Oncol. 2026 Sep 10;44(26):2517-2528. doi: 10.1200/JCO-25-02508. Epub 2026 Aug 3.

    PubMed 42546248

  • 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.

    PubMed 36048453

  • 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.

    PubMed 30575490

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mFolfirinox and Gemcitabine in people with Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), run by UNICANCER at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival (DFS) (time frame: 3 YEARS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01526135, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

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