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Pancreatic CancerPhase 3NEOPANNCT02539537

A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

A Phase 3 study testing Gemcitabine, Folinic Acid and 5-Fluoro-uracil in people with Pancreatic Cancer and Carcinoma, run by UNICANCER at 45 sites in France.

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

French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Carcinoma
What is being tested?
Gemcitabine, Folinic Acid and 5-Fluoro-uracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
45 sitesFrance
Study dates
23 Oct 2015to 25 Sep 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Proven unresectability after multidisciplinary discussion involving radiologist and a surgeon
  • Locally advanced (i.e.: no metastasis or suspicion of metastasis) and unresectable tumors: for example mesenteric or portal vein involvement, or > 180° encasement of the superior mesenteric artery, or celiac abutment (NCCN 2012 criteria)
  • Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST 1.1
  • WHO Performance status (PS) 0-1
  • Age ≥18 years
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  • Patient with organ function as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
  • Hemoglobin ≥ 10 g/dL
  • Platelets (PTL) ≥ 75 x 10⁹/L
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 x ULN
  • Creatinine ≤ 2 x ULN
  • Albumin > 0.75 x lower limit of normal (LLN)
  • Urea ≤ 2 x ULN
  • Adequate vital functions
  • Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use medically acceptable methods of contraception during the study and for 4 months after the last intake of study treatment for women and for 6 months after for men.
  • Patient information and signed informed consent form
  • Public or private health insurance coverage
  • Uracilemia < 16 ng/ml

Who cannot join

  • Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or in situ cervical cancer
  • Patient with metastasis or with history of metastasis
  • Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline)
  • Major comorbidity, active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes that may preclude the delivery of the treatment
  • Pre-existing neuropathy (Grade ≥ 2), Gilbert's disease or genotype UGT1A1 * 28 / * 28
  • Pregnant woman
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  • Fructose intolerance
  • Patients currently treated by warfarin
  • Persons deprived of liberty or under guardianship
  • Psychological condition, family-, sociological- or geographical situation potentially hampering compliance with the study protocol and the follow-up schedule

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

France45 sites

  • Centre Hospitalier Intercommunal Aix-Pertuis

    Aix-en-Provence, 13100

  • CHU Amiens - Hôpital Nord

    Amiens

  • CHU d'Angers

    Angers

  • Centre hospitalier d'Auxerre

    Auxerre

  • Centre hospitalier Henri Duffaut

    Avignon

  • Hôpital Avicenne

    Bobigny, 93000

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord

    Bordeaux, 33077

  • CH Boulogne sur Mer

    Boulogne-sur-Mer, 62321

  • CHU Côte de Nacre

    Caen, 14033

  • Centre François Baclesse

    Caen, 14076

  • Hôpital Trousseau

    Chambray-lès-Tours

  • Hôpitaux civils de Colmar

    Colmar

  • CH de Dijon

    Dijon

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Centre Hospitalier de Laon

    Laon, 02000

  • Centre Oscar Lambret

    Lille, 59020

  • CHU de Limoges

    Limoges

  • Hôpital Edouard Herriot - Lyon

    Lyon, 69437

  • Hôpital Saint Joseph Saint Luc

    Lyon

  • Hôptal Européen

    Marseille, 13003

  • Hôpital De La Timone

    Marseille, 13365

  • Centre Hospitalier de Meaux

    Meaux, 77000

  • Groupe Hospitalier du Havre Jacques Monod

    Montivilliers

  • CHU Hotel Dieu

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • CHR d'Orléans La Source

    Orléans

  • Hôpital Saint Antoine

    Paris, 75571

  • Groupe hospitalier Paris Saint Joseph

    Paris

  • Groupe hospitalier Pitié Salpétrière

    Paris

  • CH Annecy Genevois

    Pringy

  • CHU - Robert Debre

    Reims, 51092

  • CHU Rouen

    Rouen

  • CHI Elbeuf

    Saint-Aubin-lès-Elbeuf

  • Hôpital Privé des Côtes d'Armor

    Saint-Brieuc, 22190

  • Centre Regional René Gauducheau

    Saint-Herblain

  • Clinique mutualiste de l'Estuaire

    Saint-Nazaire

  • Institut de cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Hôpital privé Saint Claude

    Saint-Quentin

  • Centre Hospitalier de Soissons

    Soissons, 02209

  • Centre Hospitalier de Saint Malo

    St-Malo, 35403

  • Centre Paul Strass

    Strasbourg

  • Polyclinique de l'Ormeau-GROP

    Tarbes

  • Centre Hospitalier de Rangueil

    Toulouse, 31059

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.

Read the detailed description

Comparative interventional prospective phase 3, randomized, open-label, multicentric trial comparing chemotherapy with Folfirinox to Gemcitabine in locally advanced pancreatic carcinoma.

Being tested
Gemcitabine, Folinic Acid, 5-Fluoro-uracil, Oxaliplatin, Irinotecan
Keywords
locally advanced pancreatic carcinoma, FOLFIRINOX
Medical subject headings
Pancreatic Neoplasms, Carcinoma

What participants receive

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

Study groups in NCT02539537
Study groupRoleWhat they receive
Arm A: GemcitabineActive comparatorGemcitabine 1000 mg/m² IV infusion over 30 minutes on D1 of each week for the 4 weeks of the first cycle (1 cycle = 4 weeks). For the following five cycles, gemcitabine infusion on D1, D8, and D15 of each cycle, followed by 1 week without injection (i.e. in total 4 cycles over 24 weeks; with 19 administrations of Gemcitabine).
Receives: Drug: Gemcitabine
Arm B: FolfirinoxExperimentalAdministered once every 14 days for 24 weeks (12 cycles). A cycle equals 14 days with injection on D1 of each cycle. Treatment starts with oxaliplatin (85 mg/m²) administration; IV infusion over 2 hours, followed by the simultaneous administration (using a Y-tubing) of folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours and irinotecan 180 mg/m² IV infusion over 90 minutes. The irinotecan will begin 30 minutes after the start of the folinic acid infusion. 5-Fluoro-uracil (5-FU) IV 2,400 mg/m²/h will be administered over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m²/day for the duration of 2 days. Treatment will be continued for 24 weeks (12 cycles).
Receives: Drug: Folinic Acid; Drug: 5-Fluoro-uracil; Drug: Oxaliplatin; Drug: Irinotecan; Drug: L-folinic

What is being measured

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

  1. Progression-Free-Survival (PFS)

    To compare Progression-Free-Survival (PFS) between the two treatment arms

    Measured: From randomization until disease progression or date of death, assessed up until to 128 weeks

Secondary outcomes (8)

  1. Composite index for treatment early severe toxicity

    Biliary tract infection Grade 3-4 + any grade 5 toxicities + chemotherapy interruption for toxicity during the first four cycles.

    Measured: First four chemotherapy cycles, 16 weeks

  2. Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy

    Observance of chemotherapy

    Measured: During treatment phase, 24 weeks

  3. Overall Survival

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.

    Measured: Until death, assessed up 128 weeks after randomization

  4. Progression-free survival: pattern of failure

    The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    Measured: Until Disease Progression, assessed uo until 128 weeks after randomization

  5. Percentage of secondarily curative-intent surgery

    Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology.

    Measured: Until surgery, if applicable, up until 128 weeks after randomization

  6. Objective tumour response, disease control and their duration

    Objective tumour response, disease control and their duration (RECIST version 1.1),

    Measured: Until disease progression or date of death, assessed up until 128 weeks after randomization

  7. Time to treatment failure

    Time to treatment failure

    Measured: From randomisation to the end of treatment

  8. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: assessed up until 128 weeks after randomization

Timeline

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

  1. First posted3 Sep 2015 (estimated)
  2. Study start23 Oct 2015
  3. Primary completionFeb 2022
  4. Study completion25 Sep 2023

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
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539537
Sponsor's protocol ID
PRODIGE 29 (UCGI 26)
Other IDs
2014-003510-82, 2014
Acronym
NEOPAN
Status last verified
Jan 2024
First submitted
3 Aug 2015
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

Publications

  • Ducreux M, Desgrippes R, Rinaldi Y, Di Fiore F, Guimbaud R, Evesque L, Bachet JB, Vanelslander P, Lecomte T, Capitain O, Parzy A, Bolliet M, Etienne PL, Forestier J, El Hajbi F, Bignon AL, Lebrun-Ly V, De Sousa Carvalho N, Texier M, Bouche O. PRODIGE 29-UCGI 26 (NEOPAN): A Phase III Randomized Trial Comparing Chemotherapy With FOLFIRINOX or Gemcitabine in Locally Advanced Pancreatic Carcinoma. J Clin Oncol. 2025 Jul 10;43(20):2255-2264. doi: 10.1200/JCO-24-02210. Epub 2025 May 16.

    PubMed 40378359

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Folinic Acid and 5-Fluoro-uracil in people with Pancreatic Cancer and Carcinoma, run by UNICANCER at 45 sites in France.

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 20 inclusion and 10 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. 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?

Progression-Free-Survival (PFS) (time frame: From randomization until disease progression or date of death, assessed up until to 128 weeks). 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 NCT02539537, which also lists 1 linked publication.

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 9 Jan 2024.

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