Study protocol of a phase II clinical trial (KSCC1501A) examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

BMC Cancer

Kyushu Study group of Clinical Cancer (KSCC)¹  Eishi Baba²  Hideo Baba³  Yoshihiko Maehara⁴  Eiji Oki⁴  Hiroshi Saeki⁴  Yoshito Akagi⁵  Yasunori Emi⁶  Yoshihiro Kakeji⁷  Shoji Tokunaga⁸ 

[1] ;Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University;Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University;Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University;Department of Surgery, Kurume University School of Medicine;Department of Surgery, Saiseikai Fukuoka General Hospital;Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University;Medical Information Center, Kyushu University Hospital;

关键词: Metastatic gastric cancer;    First-line chemotherapy;    Oxaliplatin;    S-1;    Japanese patients;   

DOI  :  10.1186/s12885-017-3937-6

来源: DOAJ

【 摘 要 】

Abstract Background Oxaliplatin + S-1 is a recognized treatment regimen in Japan, but there are no Japanese clinical data on an oxaliplatin dose of 130 mg/m2. The current research involves a single-arm, prospective, phase II clinical trial to examine the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg/m2 to treat HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy in Japan. Methods/design The primary endpoint of this trial will be the response rate, and the secondary endpoints will be the safety profile of oxaliplatin + S-1, progression-free survival, the response rate in subjects under the age of 75, overall survival, time to treatment failure, duration of treatment, time to failure of strategy, and dose intensity. The threshold response rate is 45% and the expected response rate is 60%. Assuming that a one-tailed score test will be performed with an α of 0.05, 68 patients are needed to ensure a statistical power of 80%. Planned enrollment is 70 subjects and the total duration of this trial is expected to be 3 years. Discussion Since replacing cisplatin with oxaliplatin should provide the same level of therapeutic efficacy while limiting adverse events and simplifying treatment, oxaliplatin + S-1 may be increasingly used to treat gastric cancer in Japan. Verifying the efficacy and safety of oxaliplatin + S-1 with an oxaliplatin dose of 130 mg is an important task that the current trial has set out to achieve. Trial registration The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID UMIN000017550) on May 29, 2015. The details are available at the following web address: http://www.umin.ac.jp/ctr/ .

【 授权许可】

Unknown