title: Prospective phase II study of preoperative chemoradiation with capecitabine in locally advanced rectal cancer.
abstract: OBJECTIVE
  Capecitabine is an attractive oral chemotherapeutic agent that has a radiosensitizing effect and tumor-selectivity. This study was performed to evaluate the efficacy and toxicity of preoperative chemoradiation therapy, when used with oral capecitabine, for locally advanced rectal cancer.
  
  
  METHODS
  A prospective phase II trial of preoperative chemoradiation for locally advanced adenocarcinomas of the lower two-thirds of the rectum was conducted. A radiation dose of 50 Gy over five weeks and a daily dose of 1650 mg/m(2) capecitabine in two portions was administered during the entire course of radiation therapy. Surgery was performed with standardized total mesorectal excision four to six weeks after completion of the chemoradiation.
  
  
  RESULTS
  Between January 2002 and September 2003, 61 patients were enrolled onto this prospective phase II trial. The pretreatment clinical stages were T3 in 64% (n=39), T4 in 36% (n=22) and N1-2 in 82% (n=50) of these patients. Fifty-six (92%) patients completed the chemoradiation as initially planned and a complete resection performed in 58 (95%). Down-staging was observed in 45 patients (74%) and a pathologic complete response in 6 (10%). Among the 37 patients with tumors located within 5 cm from the anal verge on colonoscopy, 27 (73%) underwent a sphincter-preserving procedure. No grade 3 and 4 proctitis or hematological toxicities were observed.
  
  
  CONCLUSIONS
  Preoperative chemoradiation therapy with capecitabine achieved encouraging rates of tumor downstaging and sphincter preservation, with a low toxicity profile. This combined modality can be regarded as a safe and effective treatment for locally advanced rectal cancer.
authors.affiliation: Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jin-hong
authors.initials: JH
authors.lastname: Park
authors.forename: Jong Hoon
authors.initials: JH
authors.lastname: Kim
authors.forename: Seung Do
authors.initials: SD
authors.lastname: Ahn
authors.forename: Sang-wook
authors.initials: SW
authors.lastname: Lee
authors.forename: Seong Soo
authors.initials: SS
authors.lastname: Shin
authors.forename: Jin Cheon
authors.initials: JC
authors.lastname: Kim
authors.forename: Chang Sik
authors.initials: CS
authors.lastname: Yu
authors.forename: Hee Cheol
authors.initials: HC
authors.lastname: Kim
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
authors.forename: Heung Moon
authors.initials: HM
authors.lastname: Chang
authors.forename: Min Hee
authors.initials: MH
authors.lastname: Ryu
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Choi