title: Prospective feasibility study to evaluate neoadjuvant-synchronous S-1 + RT for locally advanced rectal cancer: a multicenter phase II trial (UMIN ID: 03396).
abstract: In Western countries, the standard treatment for locally advanced rectal cancer is preoperative chemoradiotherapy followed by total mesorectal excision. However, in Japan, the treatment results without preoperative chemoradiotherapy are by no means inferior; therefore, extrapolation of the results of preoperative treatment in Western countries to Japan is controversial. We consider that survival may be improved by preoperative chemoradiotherapy with new anticancer agents as they are expected not only to decrease the local recurrence rate but also to prevent distant metastases. We are conducting a multicentre Phase II study to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy using S-1 in patients with locally advanced rectal cancer. The primary endpoint is the rate of complete treatment of neoadjuvant chemoradiotherapy. Secondary endpoints are the response rate of neoadjuvant chemoradiotherapy, short-term clinical outcomes, rate of curative resection and pathological evaluation. The short-term clinical outcomes are adverse events of neoadjuvant chemoradiotherapy and surgery-related complications. Thirty-five patients are required for this study.
authors.affiliation: Department of Gastroenterological Surgery, Oita University Faculty of Medicine, 1-1 Idaigaoka, Hasama-machi, Oita, Japan. inomata@oita-u.ac.jp
authors.forename: Masafumi
authors.initials: M
authors.lastname: Inomata
authors.forename: Tomonori
authors.initials: T
authors.lastname: Akagi
authors.forename: Kentaro
authors.initials: K
authors.lastname: Nakajima
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Etoh
authors.forename: Norio
authors.initials: N
authors.lastname: Shiraishi
authors.forename: Koichiro
authors.initials: K
authors.lastname: Tahara
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Tadahiko
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Kyuzo
authors.initials: K
authors.lastname: Fujii
authors.forename: Akio
authors.initials: A
authors.lastname: Shiromizu
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Kubo
authors.forename: Seigo
authors.initials: S
authors.lastname: Kitano
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D002985:Clinical Protocols; D004338:Drug Combinations; D005240:Feasibility Studies; D006801:Humans; D020360:Neoadjuvant Therapy / Q000379:methods; D010094:Oxonic Acid / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000628:therapy*; D005641:Tegafur / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid