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...

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2021 Aug 27

PMID 34446057

Citations 8

Authors

Daisaku Yamada

Shogo Kobayashi

Hidenori Takahashi

Hirofumi Akita

Terumasa Yamada

Tadafumi Asaoka

Junzo Shimizu

Yutaka Takeda

Shigekazu Yokoyama

Masanori Tsujie

Akira Tomokuni

Masahiro Tanemura

Osakuni Morimoto

Masahiro Murakami

Yongkook Kim

Shin Nakahira

Naoki Hama

Keishi Sugimoto

Kazuhiko Hashimoto

Yuichiro Doki

Hidetoshi Eguchi

Affiliations

Soon will be listed here.

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.

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Results of a Randomized Clinical Study of Gemcitabine Plus Nab-Paclitaxel Versus Gemcitabine Plus S-1 as Neoadjuvant Chemotherapy for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma (RCT, CSGO-HBP-015).

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Furukawa M, Ishii Y, Serikawa M, Tsuboi T, Tatsukawa Y, Hirano T J Clin Med. 2023; 12(19).

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