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Risk-adapted adjuvant chemotherapy guided by the tumour stage for operated pancreatic adenocarcinoma following neoadjuvant chemotherapy with FOLFIRINOX FRENCH26 – PRODIGE93 - PANACHE02 Trial
EU CTIS ID: 2024-519048-33-00
What this study is testing
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
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 10. Read and understood the information letter and signed the consent form
- 2. Performans status ECOG 0 or 1
- 3. CA 19-9 level ≤ 200 U/ml
- 4. Age 18 or over
- 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)
You likely can't join if
- 1. Metastatic PAC on post-operative imaging
- 10. Person participating to another interventional research having the same primary endpoint
- 11. Person deprived of liberty by an administrative or judiciary 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 SmPC’s of the products used in this trial (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid or Leucovorin, Irinotecan, Fluorouracil)
- 2. Cholangiocarcinoma, ampullary carcinoma or other Non PAC pancreatic tumors
See the full eligibility criteria
Who can join
- 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.
- 10. Read and understood the information letter and signed the consent form
- 2. Performans status ECOG 0 or 1
- 3. CA 19-9 level ≤ 200 U/ml
- 4. Age 18 or over
- 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. 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. For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment.
- 8. Patient affiliated with, or beneficiary of a social security (national health insurance) plan
- 9. Patient able to comply with the study protocol, in the investigator’s judgment
What rules you out
- 1. Metastatic PAC on post-operative imaging
- 10. Person participating to another interventional research having the same primary endpoint
- 11. Person deprived of liberty by an administrative or judiciary 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 SmPC’s of the products used in this trial (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid or Leucovorin, Irinotecan, Fluorouracil)
- 2. Cholangiocarcinoma, ampullary carcinoma or other Non PAC pancreatic tumors
- 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. Major non-controlled infection, chronic infectious diseases, immune deficiency syndromes
- 5. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
- 6. Severe liver failure
- 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. 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. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.