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 | |||||
| NEONAX | ||||||
| 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) | ||||||
| NEPAFOX | Neoadjuvant FOLFIRINOX+adjuvant FOLFIRINOX | |||||
| 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