Neoadjuvant therapy for resectable pancreatic cancer

Table 4 List of ongoing phase II and phase III trials comparing neoadjuvant therapies vs adjuvant strategies for resectable pancreatic adenocarcinoma

Study	Design	No. of patients needed	Therapy	Primary outcome
NEOPAC (NCT01314027)	Phase III Enrollment 2009-2014	350	Neoadjuvant gemcitabineoxaliplatin + adjuvant gemcitabine vs Adjuvant gemcitabine	Progression free survival
NEOPAC (NCT01521702)	Phase III Initiated in 2011	310	Preoperative FOLFIRINOX, followed by adjuvant gemcitabine after surgery vs adjuvant gemcitabine after resection	Five-year progression free survival
NCT01900327	Phase III	410	Neoadjuvant gemcitabine-based chemoradiation therapy followed by adjuvant gemcitabine vs adjuvant gemcitabine	Three-year overall survival
NCT01771146	Phase II	100	Neoadjuvant FOLFIRINOX	Progression free survival
NEONAX (NCT02047513)	Randomized phase II	166	Neoadjuvant gemcitabine + nab-paclitaxel followed by adjuvant gemcitabine + nab-paclitaxel vs adjuvant gemcitabine + nab-paclitaxel	Disease-free survival at 18 mo
NCT01150630	Randomized phase II/III	370	Adjuvant PEXG vs adjuvant gemcitabine vs neoadjuvant PEXG - followed by surgery and then adjuvant PEXG	One year event-free survival
ACOSOG-Z5041 (NCT00733746)	Phase II	123	Neoadjuvant gemcitabine + erlotinib (completed; results pending)	Two-year overall survival
NCT00727441	Phase II	87	Neoadjuvant GVAX +/- IV or oral cyclophosphamide followed by adjuvant gemcitabine + CRT	Safety, feasibility, and immune response
NCT02178709	Phase II	48	Neoadjuvant FOLFIRINOX	Pathologic complete response
GEMCAD1003 (NCT01389440)	Phase II	24	Neoadjuvant gemcitabine + erlotinib	R0 resection rate
NCT02562716	Phase II Enrollment 2015-2019	112	Neoadjuvant and adjuvant mFOLFIRINOX vs neoadjuvant and adjuvant Nab-paclitaxel and gemcitabine	Overall survival
NCT02243007	Randomized phase II	112	Neoadjuvant FOLFIRINOX vs gemcitabine + nab-paclitaxel	18-mo overall survival
NCT02030860	Pilot	15	Neoadjuvant gemcitabine + nab-paclitaxel ± paricalcitol	Number of adverse events
NCT02305186	Randomized phase Ib/II	56	Neoadjuvant capecitabine-based CRT ± pembrolizumab (MK-3745)	Safety and immune response

CRT: Chemoradiation therapy; GVAX: Granulocyte-macrophage colony-stimulating factor gene-transfected tumor cell vaccine; PEXG: Cisplatin, epirubicin, capecitabine, gemcitabine; R0: Margin-negative surgical resection.