Prospective Cohort of Patients Treated Using Neoadjuvant Modified FOLFIRINOX 6 Cycles for Potentially Resectable Pancreatic Duct Adenocarcinoma, Candidate for Participation in the PANACHE02 Clinical Trial

NCT07034703 | Not Yet Recruiting

• 1 other identifier: 2022/0280/OB
• Study Type: observational
• Target: 820
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to build up biological, radiological and tissue collections so as to identify, at the time of diagnosis of pancreatic adenocarcinoma, multifactorial factors and/or biomarkers (tissue, plasma, radiomic) predictive of the success of the complete therapeutic sequence. So we can distinguish 3 biological collections here :

• Collection for ctDNA assay on STRECK tubes
• Collection on PAXgene tubes
• Tissus collection Considering the biology collection for ctDNA assay : blood samples will be taken on specific tubes before the start of neoadjuvant chemotherapy (C1), Before C2 and after C4 of neoadjuvant chemotherapy. For ctDN assay, 2x 10ml STRECK tubes will be taken at each point for each patient. At the end of the study, aliquots will be sent to INSERM unit U1245 to be analyzed Considering the biology collection on PAXgene tubes : 2,5 ml blood samples will be taken in PAXgene blood RNA tube before C1 for each patient Considering tissue collection: pre-chemotherapy biopsies and surgical specimens will be preserved after resection. Tissue sample will be collected and preserved in the tumor bank of Rouen university hospital, By collecting data for all screened patients (complete sequence in PANACHE02, NT failure (progression), randomization failure after surgery) at diagnosis (clinicobiological data, pre-NT biopsies, blood samples and imaging data) we first aim to refine patient selection for NT benefit with a multivariable signature approach and to identify biomarkers (blood, imaging) monitoring during the neoadjuvant phase that could be predictive of early detection for NT treatment failure. We therefore believe that the constitution of such cohort is critical to address numerous unmet needs.

Conditions

Resectable Pancreatic Duct Adenocarcinoma

Keywords

FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• factors and/or multifactorial biomarkers signature predictive of success of the complete therapeutic sequence

  In relation with the primary objective the primary endpoint of the PANACHE02 screening cohort study is the success for the complete therapeutic sequence defined by the administration of at least 4 cycles of neoadjuvant modified FOLFIRINOX following by pancreatic tumor resection and at least one cycle of adjuvant treatment. A patient evaluable for the primary endpoint is a patient for whom we the success or the failure of the complete therapeutic sequence. A patient in success for the complete therapeutic sequence is a patient with an administration of at least 4 cycles of neoadjuvant modified FOLFIRINOX following by pancreatic tumor resection and at least one cycle of adjuvant treatment. A patient in failure for the complete therapeutic sequence is a patient with an administration of less than 4 cycles of neoadjuvant modified FOLFIRINOX and/or no resection and/or no adjuvant treatment administration.

  from enrollment to the first cycle of adjuvant treatment up to 2 months

Secondary Outcomes (13)

• Overall Survival (OS) in the overall population and according to the complete therapeutic sequence status

  through study completion, an average of 76 months

• prognostic value of ctDNA at diagnosis for OS

  through study completion, an average of 76 months

• prognostic value of ctDNA at diagnosis for event free survival,

  through study completion, an average of 76 months

• tissue, serum and imaging libraries (Biological database development)

  through study completion, an average of 76 months

• factors associated with early recurrence for patients resected (< 12 months after surgical resection).

  from surgical resection to the end of follow-up period at 28 months

Study Arms (1)

mFOLFIRINOX

patients treated using Neoadjuvant modified FOLFIRINOX 6 cycles for potentially resectable pancreatic duct adenocarcinoma,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The PANACHE02 screening cohort study is a prospective national multicenter cohort study including patients with resectable pancreatic duct adenocarcinoma treated with neoadjuvant FOLFIRINOX. Of note, patients included in the PANACHE02 screening cohort study will be candidate for participation in the PANACHE02 phase II/III clinical trial to investigate risk-adapted adjuvant chemotherapy guided by the tumor stage

You may qualify if:

• Pancreatic adenocarcinoma, confirmed by a histocytological analysis
• Potentially resectable pancreatic adenocarcinoma (according to the NCCN classification; Version 2.2017). Resecability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT scan of the pancreas (slice thickness: 2.5 mm), as evaluated in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon.
• No previous chemotherapy
• Age 18 or over
• PS Grade 0 or 1
• Absolute neutrophil count \> 1,500 mm3 platelet count \> 100,000 mm3 creatinine clearance (according MDRD equation) \> 50 ml/min, haemoglobin level \> 10 g/dl (transfusions are authorized)
• Provision of informed, written consent

You may not qualify if:

• Pancreatic adenocarcinoma defined as locally advanced non-resectable or metastatic.
• Dihydropyrimidine dehydrogenase complete deficiency (uracilemia ≥ 150 ng/ml)
• Surgical or anaesthesiological contra-indications:
• non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment), long QT
• major non-controlled infection
• severe liver failure
• Any medical, psychological or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data
• Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Federation of Research in Surgery (FRENCH): collaborator

Study Sites (1)

CHU de Rouen

Rouen, France, 76031, France

Location

Study Officials

• Pr SCHWARZ

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pr SCHWARZ, PUPH

CONTACT

+33232888418; lilian.schwarz@chu-rouen.fr

Mylene HERVET

CONTACT

mylene.hervet@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): January 1, 2032
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

FR (1)