Study protocol of HGCSG1404 SNOW study : a phase I/II trial of combined chemotherapy of S-1, nab-paclitaxel and oxaliplatin administered biweekly to patients with advanced gastric cancer

Kawamoto, Yasuyuki; Komatsu, Yoshito; Yuki, Satoshi et al.

BMC cancer, 2017, 17, 837

Permalink : https://hdl.handle.net/2115/68337

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アクセス権
open access
URI
https://hdl.handle.net/2115/68337
タイトル
Study protocol of HGCSG1404 SNOW study : a phase I/II trial of combined chemotherapy of S-1, nab-paclitaxel and oxaliplatin administered biweekly to patients with advanced gastric cancer
著者
Kawamoto, Yasuyuki ; Komatsu, Yoshito ; Yuki, Satoshi ; Sawada, Kentaro ; Muranaka, Tetsuhito ; Harada, Kazuaki ; Nakatsumi, Hiroshi ; Fukushima, Hiraku ; Ishiguro, Atsushi ; Dazai, Masayoshi ; Hatanaka, Kazuteru ; Nakamura, Michio ; Iwanaga, Ichiro ; Uebayashi, Minoru ; Sogabe, Susumu ; Kobayashi, Yoshimitsu ; Miyagishima, Takuto ; Ono, Kota ; Sakamoto, Naoya ; Sakata, Yuh
著者名
Kawamoto, Yasuyuki
e-Rad_Researcher
60333598
著者名
Komatsu, Yoshito
著者名
Yuki, Satoshi
著者名
Sawada, Kentaro
著者名
Muranaka, Tetsuhito
著者名
Harada, Kazuaki
著者名
Nakatsumi, Hiroshi
著者名
Fukushima, Hiraku
著者名
Ishiguro, Atsushi
著者名
Dazai, Masayoshi
著者名
Hatanaka, Kazuteru
著者名
Nakamura, Michio
著者名
Iwanaga, Ichiro
著者名
Uebayashi, Minoru
著者名
Sogabe, Susumu
著者名
Kobayashi, Yoshimitsu
著者名
Miyagishima, Takuto
e-Rad_Researcher
10776016
著者名
Ono, Kota
e-Rad_Researcher
10334418
著者名
Sakamoto, Naoya
著者名
Sakata, Yuh
言語
英語
キーワード
Gastric cancer
Chemotherapy
S-1
Nab-paclitaxel
Oxaliplatin
発行日
2017-12-08
出版者
BioMed Central
収録物名
BMC cancer
巻(号)
17
ページ
837
抄録
Background: In Japan, S-1 plus cisplatin (SP) regimen has become a standard therapy for patients with advanced gastric cancer. Moreover, the S-1 plus oxaliplatin regimen is now a standard treatment. Nab-paclitaxel was developed for chemotherapy of gastric cancer in Japanese clinical practice. Nab-paclitaxel, created with albumin-bound paclitaxel particles, has high transferability to tumour tissues and does not cause hypersensitivity reactions because of a different chemical composition compared with docetaxel and paclitaxel. A combination of S-1, nab-paclitaxel and oxaliplatin (which we named ‘SNOW regimen’) can be a promising triplet therapy for advanced gastric cancer. Although we have to pay attention to chemotherapy-induced neuropathy, we aim to investigate the recommended dose of this regimen in a phase I study. Furthermore, we will investigate its efficacy and toxicity in a phase II study. Methods: The phase I study is a dose-escalation study using a standard 3 plus 3 design, followed by expansion cohorts. The SNOW regimen involves 28-day cycles with escalated doses of nab-paclitaxel (100-175 mg/m2 on days 1 and 15) and fixed doses of oxaliplatin (65 mg/ m2 on days 1 and 15) and S-1 (80 mg/m2/day on day 1 to 14). The primary endpoints are assessment of dose limiting toxicities and determination of maximum tolerated dose to investigate the recommended dose in the subsequent phase II study. In the phase II study, the primary endpoint is objective response rate. Secondary endpoints are assessment of safety, progression-free survival, disease control rate, overall survival and time to treatment failure. Adverse events were monitored and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Discussion: Triplet therapies for advanced gastric cancer patients have been evaluated in clinical trials. The SNOW regimen can be a promising new triplet therapy. Trial registration: This study is performed at institutes that participate in Hokkaido Gastrointestinal Cancer Study Group (HGCSG) and registered as UMIN000016788. Registrated 16 March 2015.
資源タイプ
学術雑誌論文
出版タイプ
Version of Record
権利情報
Creative Commons Attribution 4.0 International
PISSN
1471-2407
関連情報 (isIdenticalTo)
出版社版DOI
https://doi.org/10.1186/s12885-017-3850-z