Title {1} | Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma (PDAC-GS/GA-rP2, CSGO-HBP-015) |
Trial registration {2a}. | UMIN000021484 |
Protocol version {3} | Version 4.0 |
Funding {4} | This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. |
Author details {5a} |
1) 1)Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University 2) 2)Department of Gastroenterological Surgery, Osaka International Cancer Institute 3) 3)Department of Surgery, Higashiosaka City Medical Center 4) 4)Department of Gastroenterological Surgery, Osaka Police Hospital 5) 5)Department of Gastroenterological Surgery, Toyonaka Municipal Hospital 6) 6)Department of Gastroenterological Surgery, Kansai Rosai Hospital 7) 7)Department of Gastroenterological Surgery, Hyogo Prefectural Nishinomiya Hospital 8) 8)Department of Gastroenterological Surgery, Osaka Rosai Hospital 9) 9)Department of Gastroenterological Surgery, Osaka General Medical Center 10) 10)Department of Gastroenterological Surgery, Rinku General Medical Center 11) 11)Department of Surgery, Japan Community Health Care Organization Osaka Hospital 12) 12)Department of Gastroenterological Surgery, Itami City Hospital 13) 13Department of Surgery, Kaizuka City Hospital 14) 14)Department of Surgery, Sakai City Medical Center 15) 15)Department of Surgery, Ikeda City Hospital 16) 16)Department of Surgery, Minoh City Hospital 17) 17)Department of Surgery, Kindai University Nara Hospital |
Name and contact information for the trial sponsor {5b} | Hidetoshi Eguchi |
Role of sponsor {5c} | Hidetoshi Eguchi made substantial contributions to the conception and design of the study; the collection, management, analysis, and interpretation of the data; the writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities. |