Risk-adapted adjuvant chemotherapy guided by the tumour stage for operated pancreatic adenocarcinoma following neoadjuvant chemotherapy with FOLFIRINOX FRENCH26 – PRODIGE93 - PANACHE02 Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Nov 2025 → ongoing

Decision date (initial)

2025-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The main objectives are to assess the impact in term of DFS (Disease-Free Survival) (Phase 2) and OS (Phase 3) of an adjuvant chemotherapy treatment guided by pathological analysis (downstaging) (Arm A) compared to an adjuvant mFOLFIRINOX treatment regardless of pathological analysis (ArmB) in patients with resected PAC following 6 cycles of neoadjuvant modified FOLFIRINOX

Secondary objectives 7

1. • To evaluate the tolerance and safety of chemotherapy adjuvant treatments in both arms according to NCI-CTCAE V5.0
2. • To evaluate the OS for both arms in Phase 2 step
3. • To evaluate the DFS for both arms in Phase 3 step
4. • To evaluate the time to metastatic recurrence in both arms
5. • To evaluation the rate of patients with early recurrence (< 6 months after surgical resection) in both arms
6. • To evaluate the health-related quality of life (EORTC QLQ-C30 and QLQ-PAN26 questionnaires), in both arms
7. • To assess the association of tumour response guided by pathological analysis with clinic-pathological criteria (size (T stage); margins (R0/R1 status); lymph node invasion (N stage)) , DFS and OS

Conditions and MedDRA coding

resected pancreatic adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) who 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.
2. 2. Performans status ECOG 0 or 1
3. 3. CA 19-9 level ≤ 200 U/ml
4. 4. Age 18 or over
5. 5. Absolute neutrophil count > 1,500 mm3 platelet count > 100,000 mm3 creatinine clearance (according MDRD equation) > 50 ml/min, haemoglobin level > 10 g/dl (transfusions are authorized)
6. 6. 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 by B-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 treatmentand. • Women permanently sterile (hysterectomy, bilateral salpingectomy and 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 post-menopausal 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.
7. 7. For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment.
8. 8. Patient affiliated with, or beneficiary of a social security (national health insurance) plan
9. 9. Patient able to comply with the study protocol, in the investigator’s judgment
10. 10. Read and understood the information letter and signed the consent form

Exclusion criteria 13

1. 1. Metastatic PAC on post-operative imaging
2. 2. Cholangiocarcinoma, ampullary carcinoma or other Non PAC pancreatic tumors
3. 3. Non-controlled congestive heart failure – non-treated angina; recent myocardial infarction (In the previous year) – non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT
4. 4. Major non-controlled infection, chronic infectious diseases, immune deficiency syndromes
5. 5. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
6. 6. Severe liver failure
7. 7. 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
8. 8. 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 to the protocol or unable him/her to give an informed consent
9. 9. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception
10. 10. Person participating to another interventional research having the same primary endpoint
11. 11. Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or curatorship
12. Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
13. Contraindication to study adjuvant chemotherapy treatments in accordance with the SmPC’s of the products used in this trial (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid or Leucovorin, Irinotecan, Fluorouracil)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase 2: The primary efficacy endpoint is the Disease Free Survival (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 (1,53).
2. Phase 3: The primary efficacy endpoint is the Overall Survival (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

Secondary endpoints 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.
2. • OS (phase 2)
3. • DFS (Phase 3)
4. • Time to metastatic recurrence defined as the time from randomization to occurrence of distant metastases. Patients with locoregional recurrence, second pancreatic cancer, or death (all causes) without metastatic recurrence will be censored at time of event whichever occurred first. Patients free of locoregional recurrence, second pancreatic cancer, or death (all causes) without metastatic recurrence will be censored at the date of the last disease evaluation
5. • Early recurrence < 6 months after surgical randomization
6. • Health related quality of life EORTC QLQ-C30 and QLQ-PAN26 questionnaires
7. • Tumour response and clinico-pathological criteria (size (T stage); margins (R0/R1 status); lymph node invasion (N stage)), DFS and OS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

Mylene HERVET

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

Mylene HERVET

Locations

1 EU/EEA country · 37 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications