Actively Recruiting
Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX
Led by University Hospital, Rouen · Updated on 2026-02-17
390
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Rouen
Lead Sponsor
P
Partenariat de Recherche en Oncologie DIGEstive - PRODIGE
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) after 3 months of neoadjuvant mFOLFIRINOX
- Anatomically resectable or borderline resectable tumors per TNCD (2024) and ESMO (2023) guidelines
- ECOG performance status 0 or 1
- CA 19-9 level at or below 200 U/ml
- Age 18 years or older
- Absolute neutrophil count above 1,500/mm3, platelet count above 100,000/mm3, creatinine clearance above 50 ml/min, hemoglobin above 10 g/dl (transfusions allowed)
- Women of childbearing potential must use highly effective contraception from 1 month before and during chemotherapy until 15 months after treatment ends, with negative pregnancy tests
- Postmenopausal women or permanently sterile women are eligible
- Men must use contraception during the trial and for 12 months after chemotherapy ends
- Affiliated with or beneficiary of social security
- Able to comply with study protocol as judged by investigator
- Provided informed consent
You will not qualify if you...
- Presence of metastatic pancreatic adenocarcinoma on post-operative imaging
- Diagnosis of cholangiocarcinoma, ampullary carcinoma, or other non-pancreatic adenocarcinomas
- Uncontrolled heart conditions including congestive heart failure, untreated angina, recent myocardial infarction within 1 year, uncontrolled hypertension, or long QT syndrome
- Major uncontrolled infections, chronic infections, or immune deficiency syndromes
- Premalignant blood disorders such as myelodysplastic syndrome
- Severe liver failure
- History of other malignancies except treated basal/squamous skin cancer, in situ cervical carcinoma, or other malignancies without recurrence for at least 2 years
- Any medical, psychological, or social condition limiting protocol compliance or informed consent
- Pregnant or breastfeeding women and women of childbearing age not using effective contraception
- Participation in another interventional study with the same primary endpoint
- Persons deprived of liberty or under judicial protection
- Uracilemia at or above 150 ng/ml indicating complete DPD deficiency
- Contraindications to study chemotherapy drugs (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid/Leucovorin, Irinotecan, Fluorouracil)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Rouen
Rouen, France
Actively Recruiting
Research Team
L
Lilian SCHWARZ, PUPH
CONTACT
M
Mylene HERVET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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