Resectable Pancreatic Duct AdenocarcinomaPANACHE02-SCNCT07034703
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
An observational study of Resectable Pancreatic Duct Adenocarcinoma, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Duct Adenocarcinoma
- How many people
- 820 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
- Women of child-bearing age not having undergone a hysterectomy or tubal ligation - requirement for a pregnancy test (abnormal serum or urine beta-HCG level) before inclusion.
- Provision of informed, written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mylene HERVET contact
France1 site
CHU de Rouen
Rouen, France, 76031
Pr SCHWARZ, +332 32 88 84 18, lilian.schwarz@chu-rouen.fr
Mylene HERVET, mylene.hervet@chu-rouen.fr
About this study
Official title: 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 PANACHE02-SC
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 :
Read more
- 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.
- Keywords
- FOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFIRINOX | patients treated using Neoadjuvant modified FOLFIRINOX 6 cycles for potentially resectable pancreatic duct adenocarcinoma, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: through study completion, an average of 76 months
prognostic value of ctDNA at diagnosis for OS
extraction of ctDNA, then quantification by fluorimetry before being analyzed by digital PCR (dPCR)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: from enrollment to the adjuvant treatment period, an average of 5 months
factors at diagnosis associated with the access to adjuvant treatment
Measured: 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
Measured: 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)
Measured: 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)
Measured: from enrollment to 90 days post operatively
value of the tumour response
size, T stage; resection margins, criterion R; lymph node invasion, N stage
Measured: 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
Measured: 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)
Measured: from enrollment to the end of follow-up period at 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic Duct AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Federation of Research in Surgery (FRENCH)
- Responsible party
- Sponsor
- Investigators
- Pr SCHWARZ, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034703
- Sponsor's protocol ID
- 2022/0280/OB
- Acronym
- PANACHE02-SC
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 PANACHE02-SC
- ClinicalTrials.gov ID
- NCT07034703
- Acronym / sponsor ID
- PANACHE02-SC / 2022/0280/OB
- Keywords
- FOLFIRINOX
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Federation of Research in Surgery (FRENCH)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFIRINOX | – | –patients treated using Neoadjuvant modified FOLFIRINOX 6 cycles for potentially resectable pancreatic duct adenocarcinoma, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
factors and/or multifactorial biomarkers signature predictive of success of the complete therapeutic sequence
Time frame: from enrollment to the first cycle of adjuvant treatment up to 2 months
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.
13 secondary outcomes
Overall Survival (OS) in the overall population and according to the complete therapeutic sequence status
Time frame: through study completion, an average of 76 months
prognostic value of ctDNA at diagnosis for OS
Time frame: through study completion, an average of 76 months
prognostic value of ctDNA at diagnosis for event free survival,
Time frame: through study completion, an average of 76 months
tissue, serum and imaging libraries (Biological database development)
Time frame: through study completion, an average of 76 months
factors associated with early recurrence for patients resected (< 12 months after surgical resection).
Time frame: from surgical resection to the end of follow-up period at 28 months
the rate of patients with access to adjuvant treatment
Time frame: from enrollment to the adjuvant treatment period, an average of 5 months
factors at diagnosis associated with the access to adjuvant treatment
Time frame: from enrollment to the adjuvant treatment period at 5 months
safety and tolerance of the neoadjuvant chemotherapy
Time frame: from enrollment to 90 days post operatively
overall morbidity of the neoadjuvant chemotherapy
Time frame: from enrollment to 90 days post operatively
surgical morbidity and mortality rates
Time frame: from enrollment to 90 days post operatively
value of the tumour response
Time frame: from enrollment to the end of follow-up period at 28 months
Number of patients with complete neoadjuvant sequence
Time frame: from enrollment to the end of follow-up period at 28 months
evolution of health-related quality of life
Time frame: from enrollment to the end of follow-up period at 28 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mylene HERVET contact
Pr SCHWARZ principal investigator
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Pancreatic Duct Adenocarcinoma, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pr SCHWARZ, PUPH (+33232888418, lilian.schwarz@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
factors and/or multifactorial biomarkers signature predictive of success of the complete therapeutic sequence (time frame: from enrollment to the first cycle of adjuvant treatment up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.