Resectable Pancreatic Duct AdenocarcinomaPhase 2PANACHE01NCT02959879
Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma
A Phase 2 study testing FOLFOX neoadjuvant chemotherapy, FOLFIRINOX neoadjuvant chemotherapy and curative surgery for resectable pancreatic duct adenocarcinoma in people with Resectable Pancreatic Duct Adenocarcinoma, run by University Hospital, Rouen at 1 site in France.
Trial summary
In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed by adjuvant chemotherapy is currently the standard of care. However, the long-term results are still poor, with median disease-free and overall survival of 14 months and 23 months. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Resectable Pancreatic Duct Adenocarcinoma
- What is being tested?
- FOLFOX neoadjuvant chemotherapy, FOLFIRINOX neoadjuvant chemotherapy and curative surgery for resectable pancreatic duct adenocarcinoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 8 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology-proven, adenocarcinoma of the pancreas.
- Resectable adenocarcinoma (according to the NCCN classification 2014): absence of distant organ or distal lymph node metastases, absence of evidence of superior mesenteric vein (SMV) and portal vein distortion, tumour thrombus, or venous encasement, the existence of clear fat planes around the celiac axis, hepatic artery and superior mesenteric artery (SMA). Resectability 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 prior chemotherapy.
- Age 18 years or over.
- Ability to understand and willingness to consent to formal requirements for study participation
- Provision of written informed consent prior to any study-specific screening procedures.
Who cannot join
- PDAC defined as "borderline", locally advanced, non-resectable or metastatic.
- Prior cancer therapy for PDAC
- Surgical or anaesthesiological contra-indications: non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled arterial hypertension (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.
- History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1, according to according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0.
Show all 10Show fewer
- Known hypersensitivity reaction to any of the components of study treatments.
- Pregnancy (the absence of which must be confirmed in a ß-hCG test) or breast-feeding.
- Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
- Patients having been included in a clinical trial within the previous 4 weeks or participating in another trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)
In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed by adjuvant chemotherapy is currently the standard of care. However, the long-term results are still poor, with median disease-free and overall survival of 14 months and 23 months. The corresponding 5-year overall survival rate is 20%.
Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with rapidly progressive metastatic disease at time of preoperative restaging (surgery is then avoided in these patients), and may increase the rate of free margin resection (R0) and reduce the risk of local recurrence.
Read more
Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic settings, the objective response was low (at around 10%), whereas combination chemotherapy exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX chemotherapy has been demonstrated to be effective (in terms of response rates and progression-free survival) and well tolerated. Interestingly, the response rate is increased by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.
PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX \& FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) for resectable PDAC.
Patients with immediately resectable PDAC (definition based on the NCCN's (American National Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive postoperative chemotherapy for 4 months (8 cycles).
- Being tested
- FOLFOX neoadjuvant chemotherapy, FOLFIRINOX neoadjuvant chemotherapy, curative surgery for resectable pancreatic duct adenocarcinoma, Standard adjuvant chemotherapy, adjuvant chemotherapy
- Keywords
- FOLFOX, FOLFIRINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX neoadjuvant chemotherapyDrug
4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient
FOLFIRINOX neoadjuvant chemotherapyDrug
4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient
curative surgery for resectable pancreatic duct adenocarcinomaProcedure or surgery
curative surgery for resectable pancreatic duct adenocarcinoma
Standard adjuvant chemotherapyDrug
12 cycles of standard adjuvant chemotherapy are administrated
adjuvant chemotherapyDrug
8 cycles of standard adjuvant chemotherapy are administrated
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX neoadjuvant chemotherapy | Experimental | 4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient. Curative surgery for resectable pancreatic duct adenocarcinoma will be done after neoadjuvant chemotherapy. 8 cycles of adjuvant chemotherapy are administrated following the surgery Receives: Drug: FOLFOX neoadjuvant chemotherapy; Procedure: curative surgery for resectable pancreatic duct adenocarcinoma; Drug: adjuvant chemotherapy |
| FOLFIRINOX neoadjuvant chemotherapy | Experimental | 4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient. Curative surgery for resectable pancreatic duct adenocarcinoma will be done after neoadjuvant chemotherapy. 8 cycles of adjuvant chemotherapy are administrated following the surgery Receives: Drug: FOLFIRINOX neoadjuvant chemotherapy; Procedure: curative surgery for resectable pancreatic duct adenocarcinoma; Drug: adjuvant chemotherapy |
| standard adjuvant chemotherapy | Active comparator | Curative surgery for resectable pancreatic duct adenocarcinoma will be done after randomization.
12 cycles of standard adjuvant chemotherapy are administrated following the surgery Receives: Procedure: curative surgery for resectable pancreatic duct adenocarcinoma; Drug: Standard adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients alive
Number of patients alive is evaluated 12 months after the surgery
Measured: 12 months
Number of patients who achieved the complete chemotherapy treatment sequences
The number of patients who achieved the complete chemotherapy treatment sequences is evaluated 12 months after the surgery
Measured: 12 months
Secondary outcomes (6)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through end of treatment, an average of 12 months
Number of post-operative complications
Evaluation of post-operative complications is assessed using Dindo Clavien classification
Measured: 1 month after surgery
Number of patients alive and without recurrence
Number of patients alive is evaluated 36 months after the surgery
Measured: 36 months
Number of accomplished R0 resection surgery
Number of accomplished R0 resection surgery is evaluated by pathologists
Measured: Surgery day
Evaluation of quality of life
Evaluation of quality of life is done using EORTC QLQ C30
Measured: 4 weeks after the end of chemotherapy treatment
Evaluation of quality of life
Evaluation of quality of life is done using EORTC QLQ-PAN26
Measured: 4 weeks after the end of chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start1 Mar 2017
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- UNICANCER, Federation Francophone de Cancerologie Digestive, Federation of Research in Surgery (FRENCH), GERCOR - Multidisciplinary Oncology Cooperative Group
- Responsible party
- Sponsor
- Investigators
- Lilian SCHWARZ, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959879
- Sponsor's protocol ID
- 2014/0210/HP
- Acronym
- PANACHE01
- Status last verified
- Apr 2018
- First submitted
- 3 Nov 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarz L, Bachet JB, Meurisse A, Bouche O, Assenat E, Piessen G, Hammel P, Regenet N, Taieb J, Turrini O, Paye F, Turpin A, Souche FR, Laurent C, Kianmanesh R, Michel P, Vernerey D, Mabrut JY, Turco C, Truant S, Sa Cunha A; PANACHE01-FRENCH08-PRODIGE48 Investigators. Neoadjuvant FOLF(IRIN)OX Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Multicenter Randomized Noncomparative Phase II Trial (PANACHE01 FRENCH08 PRODIGE48 study). J Clin Oncol. 2025 Jun 10;43(17):1984-1996. doi: 10.1200/JCO-24-01378. Epub 2025 Apr 4.
PubMed 40184561Schwarz L, Vernerey D, Bachet JB, Tuech JJ, Portales F, Michel P, Cunha AS. Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy - a multicenter, non-comparative, randomized, phase II trial (PANACHE01-PRODIGE48 study). BMC Cancer. 2018 Jul 24;18(1):762. doi: 10.1186/s12885-018-4663-4.
PubMed 30041614
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)
- ClinicalTrials.gov ID
- NCT02959879
- Acronym / sponsor ID
- PANACHE01 / 2014/0210/HP
- Keywords
- FOLFOX, FOLFIRINOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- UNICANCER, Federation Francophone de Cancerologie Digestive, Federation of Research in Surgery (FRENCH), GERCOR - Multidisciplinary Oncology Cooperative Group
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 9 Nov 2016 (estimated)
- 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.
In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed by adjuvant chemotherapy is currently the standard of care. However, the long-term results are still poor, with median disease-free and overall survival of 14 months and 23 months. The corresponding 5-year overall survival rate is 20%.
Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with rapidly progressive metastatic disease at time of preoperative restaging (surgery is then avoided in these patients), and may increase the rate of free margin resection (R0) and reduce the risk of local recurrence.
Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic settings, the objective response was low (at around 10%), whereas combination chemotherapy exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX chemotherapy has been demonstrated to be effective (in terms of response rates and progression-free survival) and well tolerated. Interestingly, the response rate is increased by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.
PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX \& FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) for resectable PDAC.
Patients with immediately resectable PDAC (definition based on the NCCN's (American National Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive postoperative chemotherapy for 4 months (8 cycles).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOLFOX neoadjuvant chemotherapy | Experimental | Drug: FOLFOX neoadjuvant chemotherapy, Procedure: curative surgery for resectable pancreatic duct adenocarcinoma, Drug: adjuvant chemotherapy4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient. Curative surgery for resectable pancreatic duct adenocarcinoma will be done after neoadjuvant chemotherapy. 8 cycles of adjuvant chemotherapy are administrated following the surgery |
| FOLFIRINOX neoadjuvant chemotherapy | Experimental | Drug: FOLFIRINOX neoadjuvant chemotherapy, Procedure: curative surgery for resectable pancreatic duct adenocarcinoma, Drug: adjuvant chemotherapy4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient. Curative surgery for resectable pancreatic duct adenocarcinoma will be done after neoadjuvant chemotherapy. 8 cycles of adjuvant chemotherapy are administrated following the surgery |
| standard adjuvant chemotherapy | Active comparator | Procedure: curative surgery for resectable pancreatic duct adenocarcinoma, Drug: Standard adjuvant chemotherapyCurative surgery for resectable pancreatic duct adenocarcinoma will be done after randomization. 12 cycles of standard adjuvant chemotherapy are administrated following the surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histology-proven, adenocarcinoma of the pancreas.
- Resectable adenocarcinoma (according to the NCCN classification 2014): absence of distant organ or distal lymph node metastases, absence of evidence of superior mesenteric vein (SMV) and portal vein distortion, tumour thrombus, or venous encasement, the existence of clear fat planes around the celiac axis, hepatic artery and superior mesenteric artery (SMA). Resectability 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 prior chemotherapy.
- Age 18 years or over.
- Ability to understand and willingness to consent to formal requirements for study participation
Key exclusion criteria (10 listed)
- PDAC defined as "borderline", locally advanced, non-resectable or metastatic.
- Prior cancer therapy for PDAC
- Surgical or anaesthesiological contra-indications: non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled arterial hypertension (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOX neoadjuvant chemotherapy4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient | Drug | FOLFOX neoadjuvant chemotherapy |
| FOLFIRINOX neoadjuvant chemotherapy4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient | Drug | FOLFIRINOX neoadjuvant chemotherapy |
| curative surgery for resectable pancreatic duct adenocarcinomacurative surgery for resectable pancreatic duct adenocarcinoma | Procedure or surgery | FOLFIRINOX neoadjuvant chemotherapy, FOLFOX neoadjuvant chemotherapy, standard adjuvant chemotherapy |
| Standard adjuvant chemotherapy12 cycles of standard adjuvant chemotherapy are administrated | Drug | standard adjuvant chemotherapy |
| adjuvant chemotherapy8 cycles of standard adjuvant chemotherapy are administrated | Drug | FOLFIRINOX neoadjuvant chemotherapy, FOLFOX neoadjuvant chemotherapy |
Primary outcome
Number of patients alive
Time frame: 12 months
Number of patients alive is evaluated 12 months after the surgery
Number of patients who achieved the complete chemotherapy treatment sequences
Time frame: 12 months
The number of patients who achieved the complete chemotherapy treatment sequences is evaluated 12 months after the surgery
6 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through end of treatment, an average of 12 months
Number of post-operative complications
Time frame: 1 month after surgery
Number of patients alive and without recurrence
Time frame: 36 months
Number of accomplished R0 resection surgery
Time frame: Surgery day
Evaluation of quality of life
Time frame: 4 weeks after the end of chemotherapy treatment
Evaluation of quality of life
Time frame: 4 weeks after the end of chemotherapy treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 40184561Schwarz L, Bachet JB, Meurisse A, Bouche O, Assenat E, Piessen G, Hammel P, Regenet N, Taieb J, Turrini O, Paye F, Turpin A, Souche FR, Laurent C, Kianmanesh R, Michel P, Vernerey D, Mabrut JY, Turco C, Truant S, Sa Cunha A; PANACHE01-FRENCH08-PRODIGE48 Investigators. Neoadjuvant FOLF(IRIN)OX Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Multicenter Randomized Noncomparative Phase II Trial (PANACHE01 FRENCH08 PRODIGE48 study). J Clin Oncol. 2025 Jun 10;43(17):1984-1996. doi: 10.1200/JCO-24-01378. Epub 2025 Apr 4.
- Derived from this study: PubMed 30041614Schwarz L, Vernerey D, Bachet JB, Tuech JJ, Portales F, Michel P, Cunha AS. Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy - a multicenter, non-comparative, randomized, phase II trial (PANACHE01-PRODIGE48 study). BMC Cancer. 2018 Jul 24;18(1):762. doi: 10.1186/s12885-018-4663-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lilian SCHWARZ, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX neoadjuvant chemotherapy, FOLFIRINOX neoadjuvant chemotherapy and curative surgery for resectable pancreatic duct adenocarcinoma in people with 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 6 Feb 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients alive (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959879, which also lists 2 linked publications.
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 6 Feb 2026.