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)

Trials

Daisaku Yamada¹  Shogo Kobayashi¹  Hirofumi Akita¹  Hidetoshi Eguchi¹  Yuichiro Doki¹  Shigekazu Yokoyama²  Masahiro Murakami³  Yutaka Takeda⁴  Akira Tomokuni⁵  Hidenori Takahashi⁶  Tadafumi Asaoka⁷  Masanori Tsujie⁸  Masahiro Tanemura⁹  Junzo Shimizu^1,10  Terumasa Yamada^1,11  Naoki Hama^1,12  Osakuni Morimoto^1,13  Yongkook Kim^1,14  Kazuhiko Hashimoto^1,15  Keishi Sugimoto^1,16  Shin Nakahira^1,17 

[1] Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University;Department of Gastroenterological Surgery, Hyogo Prefectural Nishinomiya Hospital;Department of Gastroenterological Surgery, Itami City Hospital;Department of Gastroenterological Surgery, Kansai Rosai Hospital;Department of Gastroenterological Surgery, Osaka General Medical Center;Department of Gastroenterological Surgery, Osaka International Cancer Institute;Department of Gastroenterological Surgery, Osaka Police Hospital;Department of Gastroenterological Surgery, Osaka Rosai Hospital;Department of Gastroenterological Surgery, Rinku General Medical Center;Department of Gastroenterological Surgery, Toyonaka Municipal Hospital;Department of Surgery, Higashiosaka City Medical Center;Department of Surgery, Ikeda City Hospital;Department of Surgery, Japan Community Health Care Organization Osaka Hospital;Department of Surgery, Kaizuka City Hospital;Department of Surgery, Kindai University Nara Hospital;Department of Surgery, Minoh City Hospital;Department of Surgery, Sakai City Medical Center;

关键词: Pancreatic cancer;    Neoadjuvant chemotherapy;    Gemcitabine plus S-1;    Gemcitabine plus nab-paclitaxel;   

DOI  :  10.1186/s13063-021-05541-w

来源: DOAJ

【 摘 要 】

Abstract Background Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease, and multimodal strategies, such as surgery plus neoadjuvant chemotherapy (NAC)/adjuvant chemotherapy, have been attempted to improve survival in patients with localized PDAC. To date, there is one prospective study providing evidence for the superiority of a neoadjuvant strategy over upfront surgery for localized PDAC. However, which NAC regimen is optimal remains unclear. Methods A randomized, exploratory trial is performed to examine the clinical benefits of two chemotherapy regimens, gemcitabine plus S-1 (GS) and gemcitabine plus nab-paclitaxel (GA), as NAC for patients with planned PDAC resection. Patients are enrolled after the diagnosis of resectable or borderline resectable PDAC. They are randomly assigned to either NAC regimen. Adjuvant chemotherapy after curative resection is highly recommended for 6 months in both arms. The primary endpoint is tumor progression-free survival time, and secondary endpoints include the rate of curative resection, the completion rate of protocol therapy, the recurrence type, the overall survival time, and safety. The target sample size is set as at least 100. Discussion This study is the first randomized phase II study comparing GS combination therapy with GA combination therapy as NAC for localized pancreatic cancer. Trial registration UMIN Clinical Trials Registry UMIN000021484 . This trial began in April 2016.

【 授权许可】

Unknown