NCT07044453 Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX
| NCT ID | NCT07044453 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Hospital, Rouen |
| Condition | Resected Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 390 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2030-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Performance status ECOG 0 or 1 3. CA 19-9 level ≤ 200 U/ml 4. Age 18 years or over 5. 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) 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 co