RecruitingPhase 2Phase 3NCT07044453

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

Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX - A Multicenter, FRENCH-PRODIGE Randomized Comparative Phase II/III Trial FRENCH26 - PRODIGE93 - PANACHE 02 Trial


Sponsor

University Hospital, Rouen

Enrollment

390 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a risk-adapted approach to chemotherapy after surgery for pancreatic cancer, in patients who first received pre-surgery (neoadjuvant) chemotherapy with mFOLFIRINOX. Instead of giving all patients the same post-surgery treatment, this study tailors the type and intensity of chemotherapy based on how the tumor responded to the pre-surgery treatment. The goal is to optimize outcomes while minimizing side effects. **You may be eligible if...** - You are 18 or older - You have had pancreatic cancer surgically removed (R0 or R1 resection) - You received 3 months of mFOLFIRINOX chemotherapy before surgery - Your tumor was resectable or borderline resectable - You are in good physical condition (ECOG 0–1) - Your blood counts and organ function meet the required levels - Your CA 19-9 tumor marker is at or below 200 U/ml **You may NOT be eligible if...** - You did not receive mFOLFIRINOX as your pre-surgery treatment - Your surgery was not complete (R2 resection) - Your organ function does not meet the required levels - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGem/Nabpaclitaxel infusion

Downstaging and pathological response is empirically define as T1-2/N0/R0 status. If the anatomopathological analysis shows a lesion classified as T3-4 or N+ or R1, an adjuvant chemotherapy based on Gemcitabine with Nab Paclitaxel will be proposed for a period of 3 months.

DRUGmFOLFIRINOX infusion

Downstaging and pathological response is empirically define as T1-2/N0/R0 status. In that setting the patients will receive mFOLFIRINOX adjuvant chemotherapy 3 months.


Locations(1)

CHU de Rouen

Rouen, France

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NCT07044453


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