Copyright ©The Author(s) 2017.
World J Gastrointest Oncol. Dec 15, 2017; 9(12): 457-465
Published online Dec 15, 2017. doi: 10.4251/wjgo.v9.i12.457
Table 4 List of ongoing phase II and phase III trials comparing neoadjuvant therapies vs adjuvant strategies for resectable pancreatic adenocarcinoma
StudyDesignNo. of patients neededTherapyPrimary outcome
NEOPAC (NCT01314027)Phase III Enrollment 2009-2014350Neoadjuvant gemcitabineoxaliplatin + adjuvant gemcitabine vs Adjuvant gemcitabineProgression free survival
NEOPAC (NCT01521702)Phase III Initiated in 2011310Preoperative FOLFIRINOX, followed by adjuvant gemcitabine after surgery vs adjuvant gemcitabine after resectionFive-year progression free survival
NCT01900327Phase III410Neoadjuvant gemcitabine-based chemoradiation therapy followed by adjuvant gemcitabine vs adjuvant gemcitabineThree-year overall survival
NCT01771146Phase II100Neoadjuvant FOLFIRINOXProgression free survival
NEONAX (NCT02047513)Randomized phase II166Neoadjuvant gemcitabine + nab-paclitaxel followed by adjuvant gemcitabine + nab-paclitaxel vs adjuvant gemcitabine + nab-paclitaxelDisease-free survival at 18 mo
NCT01150630Randomized phase II/III370Adjuvant PEXG vs adjuvant gemcitabine vs neoadjuvant PEXG - followed by surgery and then adjuvant PEXGOne year event-free survival
ACOSOG-Z5041 (NCT00733746)Phase II123Neoadjuvant gemcitabine + erlotinib (completed; results pending)Two-year overall survival
NCT00727441Phase II87Neoadjuvant GVAX +/- IV or oral cyclophosphamide followed by adjuvant gemcitabine + CRTSafety, feasibility, and immune response
NCT02178709Phase II48Neoadjuvant FOLFIRINOXPathologic complete response
GEMCAD1003 (NCT01389440)Phase II24Neoadjuvant gemcitabine + erlotinibR0 resection rate
NCT02562716Phase II Enrollment 2015-2019112Neoadjuvant and adjuvant mFOLFIRINOX vs neoadjuvant and adjuvant Nab-paclitaxel and gemcitabineOverall survival
NCT02243007Randomized phase II112Neoadjuvant FOLFIRINOX vs gemcitabine + nab-paclitaxel18-mo overall survival
NCT02030860Pilot15Neoadjuvant gemcitabine + nab-paclitaxel ± paricalcitolNumber of adverse events
NCT02305186Randomized phase Ib/II56Neoadjuvant capecitabine-based CRT ± pembrolizumab (MK-3745)Safety and immune response