Annals of Hepato-Biliary-Pancreatic Surgery

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Table. 3.

Table. 3.

Selected ongoin trials of neoadyuvant therapy for RESECTABLE PDAC

Trial (ID) author Phase Target N Actual N Regimen Primary endpoint Current status
Neoajuvant chemotherapy
Prep02/JSAP05 Neoadjuvant gemcitabine+S1 and adjuvant S1
UMIN000009634 II/III 364 360 vs. Adjuvant S1 OS The median overall survival for the perioperative group was 36.7 vs. 26 months
Michiaki Unno (Japan)
PACT-15 Multicenter Neoadjuvant+adjuvant PEXG EFS (1 yr) Completed
NCT 01150630 II/III 98 88 vs. Adjuvant PEXG OS The median survival 38, 2 (mo) and OS at 3 and 5 years (55% and 49%, respectively), in favor of Neoadjuvant
Michele Reni (Milan-Italy) Vs. Adjuvant gemcitabine
PANACHE01/PRODIGE 48 Multicenter Neoadjuvant FOLFIRINOX×4+adjuvant×4 The study is currently recruiting participants
NCT 02959879 II 160 160 vs. Neoadjuvant FOLFOX×4+adjuvant chemotherapy×4 OS The results of this study are expected soon
Lilian Schwarz (French) vs. Adjuvant chemotherapy estándar×6
MCT 02047513 Neoadjuvant and adjuvant nab-paclitaxel+gemcitabine DFS
AIO-PACK-0313 II 166 127 vs. Adjuvant nab-paclitaxel+gemcitabine DFS The study is still in the recruitment phase
Thomas Seufferlein (Germany)
SWOG 51505 Neoadjuvant plus adjuvant FOLFIRINOX VS Complete recriutment
NCT02562716 II 112 112 neoadjuvant plus adjuvant nab-paclitaxel+gemcitabine OS The study is ongiong
Davendra Sohal (USA)
NCT01272976 II/III 126 40 vs. adjuvant gemcitabine OS The study is ongiong
Salah-Eddin (Germany)
NorPACT-1 Multicenter Neoadjuvant FOLFIRINOX×4+adjuvant gemcitabine+capecitabine×4
NCT02919787 II/III 90 90 vs. Adjuvant gemvitabine/capecitabine×6 OS The study is ongiong
Svein Dueland (Oslo-Norway)
NEOPAC Neoadjuvant GEMOX+adjuvant gemcitabine Study stopped
NCT01314027 III 310 38 vs. adjuvant gemcitabine RFS low recruitment
Heinrich (Zurich)
Neoadyuvant chemoradiation
NEOPA Multicenter Neoadjuvant gemcitabine/XRT+adjuvant gemcitabine
NCT 01900327 III 410 32 vs. adjuvant gemcitabine only OS The study terminated earlier without reporting results. Low recruitment
Jakob R. (Germany)

ID, indentification; GEMOX, gemcitabine/Oaliplatin; S1, an oral fluoropyrimidine derivative; PEXG, cisplatin, epirubicin, capecitabine, gemcitabine; RFS, recurrence-free survival; N, number of patients; OS, Overall survivial; DFS, disease-free survival; EFS, event-free survival; yr, year

Ann Hepatobiliary Pancreat Surg 2021;25:179-91
© 2021 Ann Hepatobiliary Pancreat Surg