Neoadjuvant treatment for resectable pancreatic adenocarcinoma

Table 1 Selected published neoadjuvant phase II trials in resectable pancreatic adenocarcinoma between 2006-2015

Trial/reference published year	Trial phase/patient number	Treatment regimen	Primary endpoint	Result
NCT00335543/2015[63]	II, randomized/66 (254 planned)	Upfront surgery vs chemoradiation with gemcitabine/cisplatin and radiotherapy of 55.8 Gy	Median survival	Median survival: 14.4 mo vs 17.4 mo (P = 0.96). Overall R0: 48% vs 52% (P = 0.81)
NCT00536874/2014[64]	II/38	Gemcitabine and oxaliplatin	18-mo overall survival	18-mo overall survival: 63%. Median overall survival: 27.2 mo. Resection rate was 71%, and 74% of resection was R0
NCT00490360/2008[20,65]	II/28	Gemcitabine and cisplatin	Resectability rate ≥ 70%	Resection rate was 89%, and 80% of resection was R0. Overall survival was 26.5 mo
Evans et al[21]	II/86	Chemoradiation with gemcitabine and radiotherapy of 30 Gy (in 10 fractions) for pancreatic head cancer	Clinical outcome	Overall R0: 74%. Median overall survival was 22.7 mo with a 5-yr survival of 27% (36% in R0)
Varadhachary[22]	II/90	Gemcitabine and cisplatin followed by chemoradiation with gemcitabine and radiotherapy of 30 Gy for pancreatic head cancer	Clinical outcome	Overall R0 was 58%. Additional chemotherapy did not improve clinical outcome
Palmer et al[66]	II, randomized/50	Gemcitabine vs gemcitabine and cisplatin	Resection rate	Resection rate was 54%: 9 (38%) in the gemcitabine arm and 18 (70%) in the combination arm

Table 2 Selected ongoing neoadjuvant trials for resectable pancreatic cancer

Trial	Trial phase	Treatment regimen	Primary endpoint	Planned accrual (patients)
NCT01900327 (NEOPA)	III	Chemoradiation with gemcitabine and radiotherapy of 50.4 Gy vs upfront surgery	3 yr survival rate	410
NCT02172976	II/III	Perioperative FOLFIRINOX vs adjuvant gemcitabine	Median overall survival	126
NCT02047513 (NEONAX)	II	Perioperative nab-paclitaxel/gemcitabine vs adjuvant nab-paclitaxel/gemcitabine	Disease free survival	166
NCT02305186	I/II	Neoadjuvant pembrolizumab plus chemoradiation with capecitabine and radiotherapy of 50.4 Gy vs neoadjuvant chemoradiation	Dose limiting toxicities; # of tumor infiltrating lymphocytes per high power field in resected tissue	56