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

Study acronym: PANACHE 02
StatusRecruiting
PhasePhase 2/3
Started2025-12-08
View on ClinicalTrials.gov ↗

Amendment history

2026-02-12
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-12-08
Eligibility criteria+25 characters
Inclusion Criteria: Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) whothat has received 3 months of neoadjuvant mFOLFIRINOX, including ana [...] s and therapeutic considerations provided in the TNCD (2024), and ESMO (2023) guidelines. PerformansPerformance status ECOG 0 or 1 CA 19-9 level ≤ 200 U/ml Age 18 years or over Absolute neutrophil count > 1,500 mm3mm³, platelet count > 100,000 mm3mm³, creatinine clearance (according to MDRD equation) > 50 ml/min, haemoglobin level > 10 g/dl (tr [...] tly sterile): with highly effective contraception (Cf. CTCG): combined (estrogen- and proges [...] [...]
Secondary endpoints6 to 7 entries
evolution of the health-related quality of life
Study sitesdetails revised at 1 of 1 site
2025-06-25
minor
Original filing
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.
Trial Details
NCT Number NCT07044453
Lead Sponsor University Hospital, Rouen
Collaborators: Partenariat de Recherche en Oncologie DIGEstive - PRODIGE, Federation de recherche en chirurgie digestive (FRENCH)
Conditions Resected Pancreatic Adenocarcinoma
Enrollment 390 participants
Start Date 2025-12-08
Primary Completion 2030-09 (estimated)
Study Completion 2032-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-17