Resectable Pancreatic Duct Adenocarcinoma Clinical Trial
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.
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).
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