Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX
PANACHE 02
Other study identifiers
Sponsor study identifier
Secondary identifiers
CTIS
interventional
390
1 country
1
Study Start
December 8, 2025
Actual (reported)Primary Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- recruiting
- Estimated enrollment
- 390 participants
- Study completion date
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
June 13, 2025
Actual (reported)First Posted
July 1, 2025
Actual (reported)Study Start
December 8, 2025
Actual (reported)Primary Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- February 17, 2026
- Status Verified
- February 2026
- Last Update Submitted
- February 12, 2026