AzTrials
AzTrials

Pancreatic CarcinomaPhase 2NCT02676349

Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

A Phase 2 study testing mFolfirinox, Chemoradiotherapy and surgery in people with Pancreatic Carcinoma, run by Institut de Cancérologie de Lorraine at 26 sites in France.

Completed

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

Official record
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Trial summary

This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Carcinoma
What is being tested?
mFolfirinox, Chemoradiotherapy and surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
26 sitesFrance
Study dates
13 Oct 2016to Dec 2025
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG performance status 0 or 1
  • Adult patients ≥ 18 years and ≤ 75 years of age
  • Histologic or cytologic proven adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred)
  • Confirmation by independent multidisciplinary expert review of borderline resectable status, according to NCCN-Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma", version 1.2015.
  • Adequate hematologic function, as follows:
  • absolute neutrophil count (ANC) ≥ > 2000/mm3
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  • platelet count ≥ 100 000/mm3
  • haemoglobin ≥ 10 g/dL
  • Adequate renal, hepatic and bone marrow function, defined as:
  • Calculated creatinine clearance ≥ 50 mL/min according to MDRD formula
  • Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. Patients with a biliary short metal stent due to cancer obstruction may be included provided that high-quality imaging is performed before stenting and bilirubin level after stent insertion decreased to ≤ 20 mg/L (≤ 34 µmol/l), and there is no cholangitis.
  • Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner)
  • for male subject: during the treatment and for up to 6 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.
  • for female subject: during the treatment and for up to 4 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.
  • Ability to provide written informed consent before the start of any study specific procedures
  • Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Who cannot join

  • Any previous treatment of the pancreatic cancer except biliary short metal stenting (chemotherapy, targeted tumor therapy, local ablative therapy, previous irradiation within the actual fields of planned radiotherapy)
  • Evidence of distant metastases including ascites
  • Evidence of extent of pancreatic cancer beyond that defined as "borderline resectable" : suspicious lymphadenopathy outside of the standard field of resection (i.e., aortocaval nodes, distant abdominal nodes)
  • Contraindication for pancreas resection
  • Pregnant or breast feeding females
  • Patients with known Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism
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  • Uracilemia ≥ 16ng/mL either a partial or complete deficiency in dihydropyrimidine dehydrogenase (DPD)
  • Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit that can be interfering with the objectives of the study
  • Previous or concurrent malignant tumor disease other than underlying tumor disease (with the exception of cervical cancer in situ, adequately treated non-melanoma skin cancers, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated without chemotherapy and favourable prognosis tumors without evidence of disease for > 3 years prior to enrolment)
  • Any severe and/or uncontrolled medical conditions including but not limited to:
  • Clinically significant cardiovascular or vascular disease : angina pectoris (even controlled), previous myocardial infarction, serious uncontrolled cardiac arrhythmia, chronic heart failure, acute or chronic infectious disease requiring general treatment)
  • Acute and chronic, active infectious disorders that requires systemic treatment
  • Peripheral polyneuropathy > grade 1
  • Any previous inflammatory disease of colon or rectum
  • Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders
  • Uncorrected disturbed electrolyte balance, in particular hypokalemia or hypocalcemia
  • Hypersensitivity against any of the study drugs (gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid), or the ingredients of these drugs (e.g. fructose).

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • Institut Bergonié

    Bordeaux

  • Polyclinique Bordeaux Nord

    Bordeaux

  • Hôpital Beaujon

    Clichy, 92110

  • Chu Colmar

    Colmar

  • Hôpital Henri Mondor (APHP)

    Créteil

  • Centre Oscar Lambret

    Lille

  • Chru Lille

    Lille

  • Infirmerie Protestante de Lyon

    Lyon

  • Hôpital Européen Marseille

    Marseille

  • Hôpital La Timone

    Marseille

  • Institut Paoli CALMETTES

    Marseille

  • Institut du Cancer de Montpellier

    Montpellier

  • Chu Nantes

    Nantes

  • Hôpital Cochin (APHP)

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • Pitié Salpêtrière (APHP)

    Paris

  • Hôpital Haut-Lévêque

    Pessac

  • CHU Reims

    Reims

  • Centre Eugène Marquis

    Rennes

  • Chu Rouen

    Rouen

  • CHP Saint Grégoire

    Saint-Grégoire

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

  • Chru Tours

    Tours

  • Chru Nancy

    Vandœuvre-lès-Nancy

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

  • Hôpital Paul Brousse

    Villejuif, 94804

Other trials in France

About this study

Official title: Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma

This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

Read the detailed description

Surgery, especially if followed by adjuvant chemotherapy, offers the only chance of cure of pancreatic cancer. At first diagnosis, after careful assessment, only 10 to 15% of patients are considered to be candidates for surgical resection and about 7% have a potentially resectable disease. These potentially resectable tumors called "borderline resectable pancreatic cancer" (BRPC) are conceptualized as those that involve the mesenteric vasculature to a limited extent and those for which resection, while possible, would likely be compromised by positive surgical margins (R1) in the absence of neoadjuvant treatment. R0 resection is indeed considered as an independent prognostic factor for survival when the surgical procedures, histological examination and definition of microscopic invasion are standardized.

The objectives of neoadjuvant treatments of BRPC is to reduce tumor volume before surgery in order to improve the chances of radical (R0) resection and to reduce the rate of lymph node positivity and recurrences. The primary outcome in published studies is usually R0 resection rate, but these results also depend on the number of margins examined and the definition of microscopic margin involvement. Prospective studies with consistent selection criteria and standardized assessment criteria are needed.

Different neoadjuvant therapeutic strategies have been tested in pilot studies: preoperative chemoradiotherapy or neoadjuvant chemotherapy, followed or not by a preoperative (chemo)radiotherapy. Due to the lack of randomized studies, the best sequence of treatment administration has not been established.

The aim of this prospective, randomized, multicenter, trial is to evaluate the R0 resection rate with neoadjuvant Folfirinox, followed or not by radiochemotherapy for patients with borderline resectable pancreatic cancers.

Being tested
mFolfirinox, Chemoradiotherapy, surgery, Adjuvant chemotherapy
Keywords
mFolfirinox, Chemoradiotherapy, Neoadjuvant treatment, Borderline
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • mFolfirinoxDrug

    oxaliplatin folinic acid irinotecan 5FU oxaliplatin

  • ChemoradiotherapyRadiation

    conformational external irradiation (50.4 Gy) + capecitabine

  • surgeryProcedure or surgery

    1 to 4 weeks after neoadjuvant treatment according to tumour response

  • Adjuvant chemotherapyDrug

    Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)

Study groups in NCT02676349
Study groupRoleWhat they receive
Arm BExperimentalNeoadjuvant chemotherapy with mFolfirinox regimen + concomitant chemoradiotherapy + surgery + adjuvant chemotherapy
Receives: Drug: mFolfirinox; Radiation: Chemoradiotherapy; Procedure: surgery; Drug: Adjuvant chemotherapy
Arm AActive comparatorNeoadjuvant chemotherapy with mFolfirinox regimen + surgery + adjuvant chemotherapy
Receives: Drug: mFolfirinox; Procedure: surgery; Drug: Adjuvant chemotherapy

What is being measured

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

  1. To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate

    Measured: up to 7.5 months

Secondary outcomes (11)

  1. Evaluate the toxicities associated with chemotherapy and chemoradiotherapy

    Measured: up to 7 years

  2. Evaluate the proportion of resected patients

    Measured: up to 7.5 months

  3. Evaluate the response rate to chemotherapy and chemoradiotherapy

    Measured: up to 7.5 months

  4. Evaluate the histological complete response rate in resected patients.

    Measured: up to 7.5 months

  5. Evaluate the perioperative mortality rate

    Measured: up to 8.5 months

  6. Evaluate the perioperative morbidity rate

    Measured: up to 8.5 months

  7. Evaluate the overall survival

    Measured: up to 7 years

  8. Evaluate the quality of life

    Measured: up to 7.5 months

  9. Evaluate the loco-regional relapse-free survival

    Measured: 7 years

  10. Evaluate the metastatic Progression Free Survival

    Measured: 7 years

  11. Evaluate the progression-free survival

    Measured: 7 years

Timeline

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

  1. First posted8 Feb 2016 (estimated)
  2. Study start13 Oct 2016
  3. Primary completion19 Apr 2024
  4. Study completionDec 2025

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02676349
Sponsor's protocol ID
2014-005681-29
Other IDs
2014
Status last verified
Mar 2026
First submitted
3 Feb 2016
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mFolfirinox, Chemoradiotherapy and surgery in people with Pancreatic Carcinoma, run by Institut de Cancérologie de Lorraine at 26 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 16 inclusion and 17 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate (time frame: up to 7.5 months). 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 NCT02676349.

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 1 Sep 2026.

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