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

BMC Cancer

Study Protocol

Yuh Sakata¹  Yoshito Komatsu²  Tetsuhito Muranaka³  Yasuyuki Kawamoto³  Kazuaki Harada³  Hiroshi Nakatsumi³  Naoya Sakamoto⁴  Satoshi Yuki⁴  Kentaro Sawada⁴  Kazuteru Hatanaka⁵  Hiraku Fukushima⁶  Ichiro Iwanaga⁷  Minoru Uebayashi⁷  Michio Nakamura⁸  Masayoshi Dazai⁹  Susumu Sogabe^1,10  Takuto Miyagishima^1,10  Yoshimitsu Kobayashi^1,10  Atsushi Ishiguro^1,11  Kota Ono^1,12 

[1] CEO, Misawa City Hospital, Misawa, Japan;Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan;Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan;Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan;Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan;Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan;Department of Gastroenterology, JCHO, Sapporo Hokushin Hospital, Sapporo, Japan;Department of Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, Japan;Department of Gastroenterology, Sapporo City General Hospital, Sapporo, Japan;Department of Gastroenterology, Sapporo Medical Center NTT EC, Sapporo, Japan;Department of Internal Medicine, Kushiro Rosai Hospital, Kushiro, Japan;Department of Medical Oncology, Teine Keijinkai Hospital, Sapporo, Japan;Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan;

关键词: Gastric cancer;    Chemotherapy;    S-1;    Nab-paclitaxel;    Oxaliplatin;   

DOI  :  10.1186/s12885-017-3850-z

 received in 2016-10-03, accepted in 2017-11-27,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsThe 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.DiscussionTriplet therapies for advanced gastric cancer patients have been evaluated in clinical trials. The SNOW regimen can be a promising new triplet therapy.Trial registrationThis study is performed at institutes that participate in Hokkaido Gastrointestinal Cancer Study Group (HGCSG) and registered as UMIN000016788. Registrated 16 March 2015.

【 授权许可】

CC BY   
© The Author(s). 2017