@article{oai:repo.qst.go.jp:00046608, author = {Wada, Hitoshi and Nemoto, Kenji and Nomiya, Takuma and Murakami, Misako and Suzuki, Motohisa and et.al and 野宮 琢磨 and 鈴木 志恒}, issue = {2}, journal = {International Journal of Clinical Oncology}, month = {Feb}, note = {BACKGROUND: The purpose of this phase I trial of S-1 chemotherapy in combination with pelvic radiotherapy for locally recurrent rectal cancer was to determine the maximum tolerated dose (MTD), recommended dose (RD), and dose-limiting toxicity (DLT) of S-1. \nMETHODS: We enrolled 9 patients between April 2005 and March 2009. Radiotherapy (total dose, 60 Gy in 30 fractions) was given to the gross local recurrent tumor and pelvic nodal metastases using three-dimensional radiotherapy planning. We administered oral S-1 twice a day on days 1-14 and 22-35 during radiotherapy. The dose of S-1 was initially 60 mg/m(2)/day and was increased to determine the MTD and RD for this regimen. \nRESULTS: DLT appeared at dose level 2 (70 mg/m(2)/day) in 2 patients, who experienced grade 3 enterocolitis and consequently required suspension of S-1 administration for longer than 2 weeks. Hematological toxicity was mild and reversible. At the initial evaluation, complete regression and partial regression were seen in 1 patient (11%) and 2 patients (22%), respectively. \nCONCLUSION: This phase I trial of S-1 chemotherapy with pelvic radiotherapy for locally recurrent rectal cancer revealed that the MTD for S-1 was 70 mg/m(2)/day and the RD was 60 mg/m(2)/day.}, pages = {273--278}, title = {A phase I trial of S-1 with concurrent radiotherapy in patients with locally recurrent rectal cancer.}, volume = {18}, year = {2012} }