A Phase 2 interventional study of FOLFOX neoadjuvant chemotherapy and FOLFIRINOX neoadjuvant chemotherapy in Resectable Pancreatic Duct Adenocarcinoma, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University Hospital, Rouen · Phase 2, Interventional, and Treatment
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).
University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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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
Drug: FOLFOX neoadjuvant chemotherapy · Procedure: curative surgery for resectable pancreatic duct adenocarcinoma · Drug: adjuvant chemotherapy
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
Drug: FOLFIRINOX neoadjuvant chemotherapy · Procedure: curative surgery for resectable pancreatic duct adenocarcinoma · Drug: adjuvant chemotherapy
Curative surgery for resectable pancreatic duct adenocarcinoma will be done after randomization. 12 cycles of standard adjuvant chemotherapy are administrated following the surgery
Procedure: curative surgery for resectable pancreatic duct adenocarcinoma · Drug: Standard adjuvant chemotherapy
4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient
4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient
curative surgery for resectable pancreatic duct adenocarcinoma
12 cycles of standard adjuvant chemotherapy are administrated
8 cycles of standard adjuvant chemotherapy are administrated
Number of patients alive
Number of patients alive is evaluated 12 months after the surgery
Time frame: 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
Time frame: 12 months
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
Time frame: 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
Time frame: 1 month after surgery
Number of patients alive and without recurrence
Number of patients alive is evaluated 36 months after the surgery
Time frame: 36 months
Number of accomplished R0 resection surgery
Number of accomplished R0 resection surgery is evaluated by pathologists
Time frame: Surgery day
Evaluation of quality of life
Evaluation of quality of life is done using EORTC QLQ C30
Time frame: 4 weeks after the end of chemotherapy treatment
Evaluation of quality of life
Evaluation of quality of life is done using EORTC QLQ-PAN26
Time frame: 4 weeks after the end of chemotherapy treatment
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen