title: [A randomized controlled trial to evaluate the effect of adjuvant oral fluoropyrimidine derivative therapy after curative resection for stage II/III rectal cancer-adjuvant chemotherapy trial of S-1 for rectal cancer (ACTS-RC):].
abstract: We are conducting a prospective randomized trial to evaluate the survival benefit of adjuvant chemotherapy with S-1 (tegafur, gimeracil, oteracil potassium) and UFT (uracil-tegafur) after curative surgery for patients with Stage II and III rectal cancer. Patients are randomized to either administration of UFT (control) or S-1. UFT was orally administered for 5 days (400 mg/m2/day) followed by two days rest for a year. S-1 was orally administered for 4 weeks (80 mg/m2/day) followed by two weeks rest for a year. The primary endpoint is relapse-free survival (RFS) rate, and the secondary endpoints are overall survival time (OS) and frequency or level of adverse events. We aim to include 400 patients in each of the treatment groups and assume that the registration period will last until 2009.
authors.affiliation: Dept. of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.forename: Rintaro
authors.initials: R
authors.lastname: Yoshida
authors.forename: Keisuke
authors.initials: K
authors.lastname: Ikeda
authors.forename: Kojiro
authors.initials: K
authors.lastname: Nishida
authors.forename: Tadashi
authors.initials: T
authors.lastname: Koga
authors.forename: Akinori
authors.initials: A
authors.lastname: Egashira
authors.forename: Eriko
authors.initials: E
authors.lastname: Tokunaga
authors.forename: Masaru
authors.initials: M
authors.lastname: Morita
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004338:Drug Combinations; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000627:therapeutic use*; D014498:Uracil / Q000008:administration & dosage
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D014498:Uracil; D010094:Oxonic Acid