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

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

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

Sponsors & Collaborators

• UNICANCER

  collaborator OTHER

• Federation Francophone de Cancerologie Digestive

  collaborator OTHER

• Federation of Research in Surgery (FRENCH)

  collaborator OTHER

• GERCOR - Multidisciplinary Oncology Cooperative Group

  collaborator OTHER

• University Hospital, Rouen

  lead OTHER

Principal Investigators

• Lilian SCHWARZ, MD · University Hospital, Rouen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-01

Primary Completion

2023-08-08

Completion

2023-08-08

Countries

• France

Study Locations