title: Study protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as adjuvant chemotherapy for stage II colon cancer.
abstract: BACKGROUND
  Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy, but the usefulness of adjuvant chemotherapy for stage II colon cancer remains controversial. The major Western guidelines recommend adjuvant chemotherapy for "high-risk stage II" cancer, but this is not clearly defined and the efficacy has not been confirmed.
  
  
  METHODS
  SACURA trial is a multicenter randomized phase III study which aims to evaluate the superiority of 1-year adjuvant treatment with UFT to observation without any adjuvant treatment after surgery for stage II colon cancer in a large population, and to identify "high-risk factors of recurrence/death" in stage II colon cancer and predictors of efficacy and adverse events of the chemotherapy. Patients aged between 20 and 80 years with curatively resected stage II colon cancer are randomly assigned to a observation group or UFT adjuvant therapy group (UFT at 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by 2-day rest. This 1-week treatment cycle is repeated for 1 year). The patients are followed up for 5 years until recurrence or death. Treatment delivery and adverse events are entered into a web-based case report form system every 3 months. The target sample size is 2,000 patients. The primary endpoint is disease-free survival, and the secondary endpoints are overall survival, recurrence-free survival, and incidence and severity of adverse events. In an additional translational study, the mRNA expression of 5-FU-related enzymes, microsatellite instability and chromosomal instability, and histopathological factors including tumor budding are assessed to evaluate correlation with recurrences, survivals and adverse events.
  
  
  CONCLUSIONS
  A total of 2,024 patients were enrolled from October 2006 to July 2010. The results of this study will provide important information that help to improve the therapeutic strategy for stage II colon cancer.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00392899.
authors: Department of Surgical Oncology, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, Tokyo 113-8519, Japan.
authors: Megumi
authors: M
authors: Ishiguro
authors: Hidetaka
authors: H
authors: Mochizuki
authors: Naohiro
authors: N
authors: Tomita
authors: Yasuhiro
authors: Y
authors: Shimada
authors: Keiichi
authors: K
authors: Takahashi
authors: Kenjiro
authors: K
authors: Kotake
authors: Masahiko
authors: M
authors: Watanabe
authors: Yukihide
authors: Y
authors: Kanemitsu
authors: Hideki
authors: H
authors: Ueno
authors: Toshiaki
authors: T
authors: Ishikawa
authors: Hiroyuki
authors: H
authors: Uetake
authors: Shigeyuki
authors: S
authors: Matsui
authors: Satoshi
authors: S
authors: Teramukai
authors: Kenichi
authors: K
authors: Sugihara
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D009367:Neoplasm Staging; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use; D014498:Uracil / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D005641:Tegafur; D014498:Uracil