title: Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02).
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety of a two-week schedule of radiotherapy with oral capecitabine in locally advanced rectal cancer.
  
  
  METHODS
  Eighty patients with rectal cancer located in the mid to low rectum, staged cT3-4N0-2M0, were prospectively enrolled. They underwent preoperative chemoradiotherapy and delayed surgery 6-8 weeks after the completion of radiation therapy. A radiation dose of 33 Gy in 10 fractions was delivered to the pelvis for 2 weeks. One cycle of oral capecitabine was administered at a dose of 1650 mg/m(2)/day during radiotherapy. Tumor response and toxicity were the study endpoints. This study was registered at ClinicalTrials.gov (number, NCT01431599).
  
  
  RESULTS
  All included patients underwent total mesorectal excisions including 12 cases of robot assisted surgery and 50 cases of laparoscopic surgery. Of the 80 patients, 27 (33.8%) achieved downstaging (ypT0-2N0) of a rectal tumor and 11 (13.8%) had a pathologically complete response (ypCR). Downstaging rates were 45% for T classification and 65% for N classification. Sphincter saving was achieved in 73 (91.3%) of the 80 patients. Of the 80 patients, 3 (3.8%) experienced grade 3 hematologic toxicity, and 2 (2.5%) had grade 3 postoperative complications such as ileus and wound dehiscence. There was no grade 4 toxicity.
  
  
  CONCLUSIONS
  A two-week schedule of radiotherapy with oral capecitabine in locally advanced rectal cancer patients showed low toxicity profiles and promising results in terms of tumor response.
authors.affiliation: Department of Radiation Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: Jong Hoon
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Colorectal Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: Jun-Gi
authors.initials: JG
authors.lastname: Kim
authors.affiliation: Department of Colorectal Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: Seong Taek
authors.initials: ST
authors.lastname: Oh
authors.affiliation: Department of Medical Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: Myung Ah
authors.initials: MA
authors.lastname: Lee
authors.affiliation: Department of Medical Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: Hoo Geun
authors.initials: HG
authors.lastname: Chun
authors.affiliation: Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Republic of Korea.
authors.forename: Dae Yong
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Republic of Korea.
authors.forename: Tae Hyun
authors.initials: TH
authors.lastname: Kim
authors.affiliation: Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Republic of Korea.
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Republic of Korea.
authors.forename: Ji Yeon
authors.initials: JY
authors.lastname: Baek
authors.affiliation: Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Republic of Korea.
authors.forename: Ji Won
authors.initials: JW
authors.lastname: Park
authors.affiliation: Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Go-Yang, Republic of Korea.
authors.forename: Jae Hwan
authors.initials: JH
authors.lastname: Oh
authors.affiliation: Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Hee Chul
authors.initials: HC
authors.lastname: Park
authors.affiliation: Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Doo Ho
authors.initials: DH
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.affiliation: Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Hee Cheol
authors.initials: HC
authors.lastname: Kim
authors.affiliation: Department of Radiation Oncology, Seoul National University College of Medicine, Republic of Korea.
authors.forename: Eui Kyu
authors.initials: EK
authors.lastname: Chie
authors.affiliation: Department of Radiation Oncology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. Electronic address: hsjang11@catholic.ac.kr.
authors.forename: Hong Seok
authors.initials: HS
authors.lastname: Jang
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000069287:Capecitabine; D059248:Chemoradiotherapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D012074:Remission Induction
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil
keywords: Preoperative chemoradiotherapy; Rectal cancer; Total mesorectal excision; Two-week course