NCT02959879

Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma

Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Resectable Pancreatic Duct Adenocarcinoma

Interventions

Type	Name	Description
DRUG	FOLFOX neoadjuvant chemotherapy	4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient
DRUG	FOLFIRINOX neoadjuvant chemotherapy	4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient
PROCEDURE	curative surgery for resectable pancreatic duct adenocarcinoma	curative surgery for resectable pancreatic duct adenocarcinoma
DRUG	Standard adjuvant chemotherapy	12 cycles of standard adjuvant chemotherapy are administrated
DRUG	adjuvant chemotherapy	8 cycles of standard adjuvant chemotherapy are administrated

Timeline

• Start date: 2017-03-01
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2016-11-09
• Last updated: 2026-02-06

Locations

1 site across 1 country: France