[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):].
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.
Oki
Eiji
E
Dept. of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kakeji
Yoshihiro
Y
Yoshida
Rintaro
R
Ikeda
Keisuke
K
Nishida
Kojiro
K
Koga
Tadashi
T
Egashira
Akinori
A
Tokunaga
Eriko
E
Morita
Masaru
M
Baba
Hideo
H
Maehara
Yoshihiko
Y
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
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D014498:Uracil; D010094:Oxonic Acid