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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

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Title: 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
Authors: Kawamoto, Yasuyuki Browse this author
Komatsu, Yoshito Browse this author →KAKEN DB
Yuki, Satoshi Browse this author
Sawada, Kentaro Browse this author
Muranaka, Tetsuhito Browse this author
Harada, Kazuaki Browse this author
Nakatsumi, Hiroshi Browse this author
Fukushima, Hiraku Browse this author
Ishiguro, Atsushi Browse this author
Dazai, Masayoshi Browse this author
Hatanaka, Kazuteru Browse this author
Nakamura, Michio Browse this author
Iwanaga, Ichiro Browse this author
Uebayashi, Minoru Browse this author
Sogabe, Susumu Browse this author
Kobayashi, Yoshimitsu Browse this author
Miyagishima, Takuto Browse this author
Ono, Kota Browse this author →KAKEN DB
Sakamoto, Naoya Browse this author →KAKEN DB
Sakata, Yuh Browse this author
Keywords: Gastric cancer
Issue Date: 8-Dec-2017
Publisher: BioMed Central
Journal Title: BMC cancer
Volume: 17
Start Page: 837
Publisher DOI: 10.1186/s12885-017-3850-z
Abstract: 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.
Type: article
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小松 嘉人

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