New challenges in perioperative management of pancreatic cancer

Table 4 Selected ongoing neoadjuvant/preoperative trials registered at clinicaltrial.gov before January 2014

Clinicaltrial.gov No.	Type of cancer	Intervention	Design	Primary outcome	Biomarker
NCT01771146	Locally advanced	FOLFIRINOX	Phase II Single arm	PFS	No
NCT01458717	Borderline resectable	Gemcitabine and CRT vs uprfont surgery	Phase II/III Randomized trial	2-yr OS	No
NCT01065870	Locally advanced	gemcitabine, capecitabine and docetaxel +/- RT with gemcitabine and capecitabine	Phase II/III Non randomized	2-yr OS	No
NCT01314027	Resectable	Neoadjuvant gemcitabine/oxaliplatin vs adjuvant CT with gemcitabine	Phase III randomized multicenter trial	PFS	No
NCT01521702	Resectable	Neoadjuvant gemcitabine/oxaliplatine vs surgery and adjuvant gemcitabine	Phase III Randomized Multicenter trial	PFS	No
NCT00536874	Resectable	Gemcitabine and oxaliplatine	Phase II Single arm	OS 18 mo	Yes (proteomic profiling, laboratory biomarker analysis)
NCT01661088	Borderline resectable	FOLFIRINOX, gemcitabine during and after radiation therapy	Phase II Single arm	R0 resection rate	No
NCT00609336	Resectable	Gemcitabine, docetaxel, capecitabine, RT and surgery	Phase II Single arm	OS	No
NCT00869258	Locally advanced	Gemcitabine, docetaxel and capecitabine followed by RT with gemcitabine	Phase II Single arm	Conversion rate	No
NCT00557492	Resectable	Bevacizumab with gemcitabine and radiation therapy	Phase II Single arm	R0 resection rate	Yes (not specified)
NCT01298011	Resectable	Gemcitabine and nab-paclitaxel	Phase II Single arm	Histological response	Yes (SPARC expression in the tumor)
NCT01359007	Borderline resectableLocally advanced	FOLFIRINOX	Phase I Single arm	R0 resection rate	No
NCT01470417	ResectableBorderline resectable	Nab-paclitaxel and gemcitabineNab-paclitaxel and gemcitabine with CT	Phase II Not randomized	Biochemical and pathologic response rateR0 resection rate	Yes (biochemical radiographic, and pathologic factors)
NCT01494155	Resectable	Capecitabine, Hydroxychloroquine and proton RT	Phase II Single arm	PFS	Yes (autophagy)
NCT00733746	Resectable	Gemcitabine and erlotinib	Phase II Single arm	OS	Yes (gene expression, polymorphism and laboratory biomarker analysis)
NCT01726582	ResectableBorderline resectable	Targeted CT prior and after surgery guided by molecular profilingCRT before surgery	Phase II Single arm	R0 resection rate	Yes (see: http://www.mcw.edu/surgery/patientinfo/pancreatic-cancer-trial.htm)
NCT01150630	Resectable	Adjuvant vs neoadjuvant Capecitabine, cisplatine, epirubicine and gemcitabine	Phase II/III Multicenter randomized trial	Event-free survival at 1 yr	No

FOLFIRINOX: 5-Fluorouracil, folinic acid, irinotecan and oxaliplatin; CRT: Chemoradiation therapy; CT: Chemotherapy; RT: Radiation therapy; PFS: Progression free survival; OS: Overall survival.