{Reference Type}: Clinical Trial, Phase I
{Title}: Phase I study of S-1 plus fractional cisplatin as adjuvant chemotherapy for advanced gastric cancer in an outpatient setting (KOGC-03).
{Author}: Takahashi T;Saikawa Y;Fukuda K;Nakamura R;Wada N;Kawakubo H;Takeuchi H;Takaishi H;Kitagawa Y;
{Journal}: Anticancer Res
{Volume}: 35
{Issue}: 1
{Year}: Jan 2015
{Factor}: 2.435
{DOI}: 
{Abstract}: <B>OBJECTIVE: </B>The aim of this phase I study was to adjust the dose of cisplatin as adjuvant combination chemotherapy with S-1 in an outpatient setting for gastric cancer.<BR><B>METHODS: </B>The first course was initiated with S-1 monotherapy on days 1-28. From the second to the sixth course, S-1 was administered on days 1-28 and cisplatin was added on days 1, 15, and 29. The dose level of cisplatin was escalated as follows: 20 mg/m(2) (level 1); 25 mg/m(2) (level 2); 30 mg/m(2) (level 3). Dose-limiting toxicity was a delay factor of the start of the next course due to incomplete recovery.<BR><B>RESULTS: </B>The maximum tolerated and recommended doses were confirmed as level 3 and level 2, respectively.<BR><B>CONCLUSIONS: </B>Although further clinical trials are recommended to evaluate efficacy, this combination of S-1 plus cisplatin regimen is expected to become a standard adjuvant treatment for gastric cancer in the outpatient setting.