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Resected Pancreatic AdenocarcinomaPhase 2/3PANACHE 02NCT07044453

Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX

A Phase 2/3 study testing Gem/Nabpaclitaxel infusion and mFOLFIRINOX infusion in people with Resected Pancreatic Adenocarcinoma, run by University Hospital, Rouen at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Induction mFOLFIRINOX has become the standard in the management of locally advanced and borderline adenocarcinoma. Following the results of the PREOPANC-01 JASP-05, NEONAX studies it is expected that the neoadjuvant approach will be the standard strategy soon in patients with resectable PAC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resected Pancreatic Adenocarcinoma
What is being tested?
Gem/Nabpaclitaxel infusion and mFOLFIRINOX infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
1 siteFrance
Study dates
8 Dec 2025to Sep 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 confirmed resected pancreatic adenocarcinoma (R0 or R1) that has received 3 months of neoadjuvant mFOLFIRINOX, including anatomically resectable and borderline resectable tumors, in accordance with the definitions and therapeutic considerations provided in the TNCD (2024) and ESMO (2023) guidelines.
  • Performance status ECOG 0 or 1
  • CA 19-9 level ≤ 200 U/ml
  • Age 18 years or over
  • Absolute neutrophil count > 1,500 mm³, platelet count > 100,000 mm³, creatinine clearance (according to MDRD equation) > 50 ml/min, haemoglobin level > 10 g/dl (transfusions are authorized)
  • Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile): with highly effective contraception (Cf. CTCG): combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month, during chemotherapy treatment and for 15 months after cessation of chemotherapy treatment, and a negative blood pregnancy test for β-HCG at inclusion as well as pregnancy tests before each cycle of adjuvant chemotherapy, then monthly throughout the study until 15 months after the end of exposure to systemic treatment. Women permanently sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy). Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
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  • For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment.
  • Patient affiliated with, or beneficiary of, a social security (national health insurance) plan
  • Patient able to comply with the study protocol, in the investigator's judgment
  • Read and understood the information letter and signed the consent form

Who cannot join

  • Metastatic PAC on post-operative imaging
  • Cholangiocarcinoma, ampullary carcinoma or other non-PAC pancreatic tumors
  • Non-controlled congestive heart failure, non-treated angina, recent myocardial infarction (in the previous year), non-controlled AHT (SBP > 160 mm Hg or DBP > 100 mm Hg, despite optimal drug treatment), long QT
  • Major non-controlled infection, chronic infectious diseases, immune deficiency syndromes
  • Premalignant hematologic disorders, e.g. myelodysplastic syndrome
  • Severe liver failure
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  • Past or current history of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix, other malignant disease without recurrence after at least 2 years of follow-up
  • Any medical, psychological or social situation that (in the investigator's opinion) could limit the patient's compliance with the protocol or the ability to obtain or interpret data or to understand the conditions required for his/her participation in the protocol or render him/her unable to give informed consent
  • Pregnant or breastfeeding women and women of childbearing age not using effective means of contraception
  • Person participating in another interventional research having the same primary endpoint
  • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship
  • Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
  • Contraindication to study adjuvant chemotherapy treatments in accordance with the SmPCs of the products used in this trial (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid or Leucovorin, Irinotecan, Fluorouracil)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lilian SCHWARZ, PUPH contact

+332 32 88 84 18

lilian.schwarz@chu-rouen.fr

Mylene HERVET contact

mylene.hervet@chu-rouen.fr

France1 site, 1 recruiting

  • CHU de Rouen

    Rouen

    Lilian SCHWARZ, PUPH, +332 32 88 84 18, lilian.schwarz@chu-rouen.fr

    Pr SCHWARZ

    Recruiting

Other trials in France

About this study

Official title: Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX - A Multicenter, FRENCH-PRODIGE Randomized Comparative Phase II/III Trial FRENCH26 - PRODIGE93 - PANACHE 02 Trial

Induction mFOLFIRINOX has become the standard in the management of locally advanced and borderline adenocarcinoma. Following the results of the PREOPANC-01 JASP-05, NEONAX studies it is expected that the neoadjuvant approach will be the standard strategy soon in patients with resectable PAC. The results of the PANACHE-01 trial confirm the feasibility of the neoadjuvant approach in the setting of resectable adenocarcinoma. Two randomized phase III studies, on the same design as PANACHE-01 are currently underway comparing neoadjuvant and adjuvant chemotherapy with mFOLFIRINOX for resectable PAC, (Alliance AO21806, NCT04340141; PREOPANC3, NCT04927780). Despite the improvement of oncosurgical management, recurrence of PAC soon after resection occurs frequently, leading to the dismal prognosis and unnecessary surgery-related loss of quality of life. Thus, there is urgent need for development of innovative and new strategies to decrease postoperative recurrence.

Important residual tumor load after NAT suggests a primary resistance of the tumor or the selection of resistant clones. The most innovative aspect of this study will be to adapt the adjuvant chemotherapy strategy to the pathological response (downstaging) in patients who will have R0-R1 resection after neoadjuvant mFOLFIRINOX, taking into account the chemoresistance/sensibility status of the tumor.

Being tested
Gem/Nabpaclitaxel infusion, mFOLFIRINOX infusion

What participants receive

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

  • Gem/Nabpaclitaxel infusionDrug

    Downstaging and pathological response is empirically define as T1-2/N0/R0 status. If the anatomopathological analysis shows a lesion classified as T3-4 or N+ or R1, an adjuvant chemotherapy based on Gemcitabine with Nab Paclitaxel will be proposed for a period of 3 months.

  • mFOLFIRINOX infusionDrug

    Downstaging and pathological response is empirically define as T1-2/N0/R0 status. In that setting the patients will receive mFOLFIRINOX adjuvant chemotherapy 3 months.

Study groups in NCT07044453
Study groupRoleWhat they receive
Experimental group - Arm A:ExperimentalAdjuvant chemotherapy guided by pathological analysis (downstaging) * pT1-2/N0/R0 status: 3 months mFOLFIRINOX adjuvant chemotherapy (no change in chemotherapy regimen compared to neoadjuvant setting) * pT3-4 or N+ or R1 status: 3 months Gemcitabine with NabPaclitaxel adjuvant chemotherapy (change in chemotherapy regimen compared to neoadjuvant setting).
Receives: Drug: Gem/Nabpaclitaxel infusion; Drug: mFOLFIRINOX infusion
Control group - Arm BActive comparator3 months mFOLFIRINOX adjuvant chemotherapy regardless of pathological analysis
Receives: Drug: mFOLFIRINOX infusion

What is being measured

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

  1. Disease Free Survival

    The primary efficacy endpoint is the Disease Free Survival at 2 years (DFS), defined as the time from randomization to locoregional recurrence, occurrence of distant metastases or second pancreatic cancer, or death (all causes) whichever occurred first. Patients free of events will be censored at the date of the last disease evaluation either during study treatment period or during follow-up period

    Measured: from enrollment up to 5 years

  2. Overall Survival

    The primary efficacy endpoint is the Overall Survival at 3 years(OS), defined as the time from randomization to the death from any cause. Alive patient will be censored at last date known to be alive either during study treatment period or during follow-up period

    Measured: from enrollment up to 7 years

Secondary outcomes (7)

  1. Incidence and grade for Adverse Events (AEs)

    drug related AEs, drug related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, according to NCI-CTCAE V5.0.

    Measured: from enrollment up to 7 years

  2. metastatic recurrence free survival in both arms

    Time to metastatic recurrence defined as the time from randomization to occurrence of distant metastases.

    Measured: from enrollment up to 7 years

  3. rate of patients with early recurrence

    Early recurrence < 6 months after surgical randomization

    Measured: from enrollment up to 5 years

  4. evolution of the health-related quality of life

    Health related quality of life EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Core 30). Scale rated from 0 to 100.

    Measured: from enrollment up to 7 years

  5. evolution of the health-related quality of life

    Health related quality of life QLQ-PAN26 questionnaire (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Pancreatic Cacner Module - 26 items). Scale rated from 0 et 100.

    Measured: from enrollment up to 7 years

  6. Correlation of tumour response with TNM classification

    TNM classification :

    T- the extent of the primary tumour (T1-T4 Increasing size) N- the absence N0 or presence (N1-N2) and extent of regional lymph node metastasis M- the absence (M0) or presence (M1) of distant metastasis

    Measured: from enrollment up to 7 years

  7. Correlation of tumour response with Residual Tumour (R) Classification

    Residual Tumour (R) Classification : R0 No residual tumour R1 Microscopic residual tumour

    Measured: from enrollment up to 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 posted1 Jul 2025
  2. Study start8 Dec 2025
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2032 (estimated)

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 2/3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07044453
Sponsor's protocol ID
2021/0377/HP
Other IDs
2024-519048-33-00
Acronym
PANACHE 02
Status last verified
Feb 2026
First submitted
13 Jun 2025
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gem/Nabpaclitaxel infusion and mFOLFIRINOX infusion in people with Resected Pancreatic Adenocarcinoma, run by University Hospital, Rouen at 1 site 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lilian SCHWARZ, PUPH (+332 32 88 84 18, lilian.schwarz@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (time frame: from enrollment up to 5 years). The study lists 2 primary outcomes in all. 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 NCT07044453.

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 17 Feb 2026.

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