| 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 |
| Chemotherapy |
| S-1 |
| Nab-paclitaxel |
| Oxaliplatin |
| 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. |
| Rights: | http://creativecommons.org/licenses/by/4.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/68337 |
| 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)
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