Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federation of Research in Surgery (FRENCH) | OTHER |
Not provided
Not provided
Not provided
Not provided
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 :
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFIRINOX | patients treated using Neoadjuvant modified FOLFIRINOX 6 cycles for potentially resectable pancreatic duct adenocarcinoma, |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the overall population and according to the complete therapeutic sequence status | Overall survival; OS will be calculated from the date of diagnosis to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period. | through study completion, an average of 76 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pancreatic adenocarcinoma defined as locally advanced non-resectable or metastatic.
Dihydropyrimidine dehydrogenase complete deficiency (uracilemia ≥ 150 ng/ml)
Surgical or anaesthesiological contra-indications:
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
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pr SCHWARZ, PUPH | Contact | +33232888418 | lilian.schwarz@chu-rouen.fr | |
| Mylene HERVET | Contact | mylene.hervet@chu-rouen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pr SCHWARZ | University Rouen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rouen | Rouen | France | 76031 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| prognostic value of ctDNA at diagnosis for OS | extraction of ctDNA, then quantification by fluorimetry before being analyzed by digital PCR (dPCR) | through study completion, an average of 76 months |
| prognostic value of ctDNA at diagnosis for event free survival, | Event-free survival (EFS) was used to evaluate the time to failure since diagnosis. A failure is defined as progression before surgery, unresectable or metastatic disease at surgical exploration and recurrence or death whatever occurred first after surgery. Alive patients with no failure will be censored at the last date known to be alive with no failure events, either during study treatment period or during follow-up period. | through study completion, an average of 76 months |
| tissue, serum and imaging libraries (Biological database development) | Assess several methods to quantify tumor response and its prognostic value. If pertinent and reproducible, the best method may better select the patients most likely to beneficiate from a chemotherapy switch than the pTNM stage. Different approaches will be compared to refine the identification of good/bad responders. | through study completion, an average of 76 months |
| factors associated with early recurrence for patients resected (< 12 months after surgical resection). | For patients resected, Disease Free Survival (DFS), is defined as the time from complete surgical resection to first documented event (cancer relapse, second malignancy, or death, whichever occurred first), or until last contact if no event occurs. Patients lost to follow-up were censored at last follow-up visit. | from surgical resection to the end of follow-up period at 28 months |
| the rate of patients with access to adjuvant treatment | Rate of patients with access to adjuvant treatment | from enrollment to the adjuvant treatment period, an average of 5 months |
| factors at diagnosis associated with the access to adjuvant treatment | from enrollment to the adjuvant treatment period at 5 months |
| safety and tolerance of the neoadjuvant chemotherapy | Safety and will be measured by the incidence and grade of AEs, SAEs, according to NCI-CTCAE v 5.0 | from enrollment to 90 days post operatively |
| overall morbidity of the neoadjuvant chemotherapy | Overall morbidity evaluated with DINDO-CLAVIEN at 30 days and 90 days post operatively The Clavien Dindo classification scale consists of several grades ranging from a postoperative event not requiring medical treatment Grade I to death Grade V (Grade I, II, IIIa, IIIb, IVa, IVb and V) | from enrollment to 90 days post operatively |
| surgical morbidity and mortality rates | Surgical morbidity and mortality rates are evaluated with DINDO-CLAVIEN at 30 days and 90 days post operatively The Clavien Dindo classification scale consists of several grades ranging from a postoperative event not requiring medical treatment Grade I to death Grade V (Grade I, II, IIIa, IIIb, IVa, IVb and V) | from enrollment to 90 days post operatively |
| value of the tumour response | size, T stage; resection margins, criterion R; lymph node invasion, N stage | from enrollment to the end of follow-up period at 28 months |
| Number of patients with complete neoadjuvant sequence | complete neoadjuvant sequence correspond to mFOLFIRINOX Cycles + curative surgery | from enrollment to the end of follow-up period at 28 months |
| evolution of health-related quality of life | (EORTC QLQ-C30 and QLQ-PAN26 questionnaires) | from enrollment to the end of follow-up period at 28 months |