TAS-118 is a novel combination antitumor agent, which the components of S-1, i.e. tegafur (FT), gimeracil (CDHP), and oteracil potassium (Oxo), are combined with calcium folinate (LV) into one granular form. In a phase II study, S-1 plus LV and oxaliplatin was more active than S-1 plus LV or S-1 plus cisplatin with acceptable toxicities for patients with advanced gastric cancer. A phase 3 study comparing TAS-118 plus oxaliplatin with S-1 plus cisplatin in advanced gastric cancer is in progress in Japan and Korea (NCT02322593). This study is designed to assess feasibility of preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin, and postoperative adjuvant therapy with TAS-118 alone or TAS-118 plus Oxaliplatin, in patients with resectable locally advanced gastric cancer with lymph node metastasis.
Histopathologically confirmed locally advanced gastric cancer pts with cT3-4N1-3M0 on image findings (Japanese Classification of Gastric Carcinoma, 14th Edition) with no distant matastasis, aged 20 to 79 years, are enrolled in this study. Eligible pts will receive the regimen consists of 3 parts: i) preoperative 4 courses of TAS-118(80-120mg/body; day1-7) plus Oxaliplatin (85mg/m2; day1) every two weeks ii) gastrectomy with D2 lymphadenectomy iii) postoperative 12 courses of TAS-118 alone(80-120mg/body;day1-7) (step1) or 8 cycles of TAS-118 plus Oxaliplatin(step2); every two weeks . The primary endpoints are feasibility of i) preoperative adjuvant chemotherapy with TAS-118 plus Oxaliplatin and gastrectomy, ii) postoperative adjuvant chemotherapy with TAS-118 alone(step1) and TAS-118 plus Oxaliplatin(step2). The target sample size is 45. Secondary endpoints include the treatment completion rate of chemotherapy and surgery, relative dose intensity, clinical and pathological response rates for preoperative chemotherapy, R0 resection rate, down staging rate, relapse free and overall survival, and safety. This IIT study is conducted in 3 sites in Japan and has initiated from November 2016.
Clinical trial identification
UMIN000024688 release date: 5 Dec 2016
Legal entity responsible for the study
A. Takashima: Speaker\'s bureau: Takeda, Chugai, Taiho, Merk Serono. Research funding: Chugai, Taiho, Merk Serono, Gilead. D. Takahari: Research funding: Taiho Honoraria: Taiho, Yakult, Lilly, Chugai. N. Ishizuka: Stock ownership: Sanofi Honoraria: Daiichi-Sankyo Adovisory role: BMS. T.E. Nakajima: Honoraria: Taiho, Eli Lilly, Chugai, Kyowa Hakko Kirin, Hisamitsu, Merck Serono, Sawai, Takeda, Bristol-Myers Squibb, Ono, Bayer, Dainippon Sumitomo. Research funding: Taiho, Eli Lilly, Chugai, Kyowa Hakko Kirin, Hisamitsu, Merck Serono, Sawai, Takeda. S. Takahashi: Honoraria: Eisai, Astellas, Taiho, Bayer, Daiichi-Sankyo, Pfizer, Astrazeneca, Merck Serono, Sanofi, Novartis, Ono, Bristol-Myers, MSD. Research funding: Eisai, Chugai, MSD, Lilly, Astrazeneca, Novartis, Taiho, Bayer, Astellas, Ono, Daiichisankyo. T. Sano: Honoraria: Taiho, Chugai, Yakult, Lilly, Eisai, Ethicon, Covidien. N. Boku: Honoraria: Lilly, Taiho, Chugai, Ono, Merck-Serono, Yakult. Research funding: Ono, Bristol-Myers Squibb, Taiho. K. Yamaguchi: Speaker\'s bureau: Takeda, Lilly, Taiho, Chugai, Merck. Research funding: Yakult, Taiho, MSD, Ono, Chugai, Lilly, Merck. All other authors have declared no conflicts of interest.