title: Treatment Rationale and Study Design for Clinical Trial on the Efficacy of UFT/LV for Stage II Colorectal Cancer With Risk Factors for Recurrence (JFMC46-1201).
abstract: BACKGROUND
  The usefulness of adjuvant chemotherapy for stage II colon cancer has not been established. Meanwhile, the presence of stage II colon cancer with high-risk factors for recurrence has been reported. To our knowledge, no prospective study of adjuvant chemotherapy for stage II colon cancer with high-risk factors has been implemented to date.
  
  
  METHODS
  This study is a prospective nonrandomized controlled study based on patients' selection of treatment option, including randomized therapeutic decision-making, to evaluate the usefulness of adjuvant chemotherapy with tegafur-uracil (UFT) with leucovorin (LV) for stage II colon cancer with high-risk factors for recurrence, compared with surgery alone. Five courses of UFT/LV therapy will be given as follows: UFT (300 mg/m(2)/d) with LV (75 mg/d) will be orally administered in 3 doses per day. Treatment will be received daily for 28 days, followed by a 7-day rest or will be received daily for 5 days, followed by a 2-day rest. For both regimens, 1 course will last 5 weeks, and 5 courses will be given. The primary end point is disease-free survival. A propensity score matching will be conducted based on 7 variables that represent risk factors to minimize selection bias in a comparison between the nonrandomized arms. For this nonrandomized comparison, a target sample size is set at 1200 (400 and 800 patients for the surgery alone and UFT/LV groups, respectively) and 1720 patients will be enrolled. In this study we aim to evaluate the therapeutic usefulness of adjuvant chemotherapy with UFT/LV for stage II colorectal cancer with risk factors for recurrence.
authors.affiliation: Department of Surgery, Tokai University, Isehara, Japan. Electronic address: sadahiro@is.icc.u-tokai.ac.jp.
authors.forename: Sotaro
authors.initials: S
authors.lastname: Sadahiro
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Department of Surgery, Otaru Ekisaikai Hospital, Otaru, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Sasaki
authors.affiliation: Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sakamoto
authors.affiliation: Department of Infectious Diseases, Hiroshima University Hospital, Hiroshima, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ohge
authors.affiliation: Department of Surgical Oncology, Gifu University School of Medicine, Gifu, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Department of Surgery, Sendai City Medical Center, Sendai, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Tsuchiya
authors.affiliation: Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Surgery, Nagoya Medical Center, Nagoya, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kondo
authors.affiliation: Department of Surgery, Kurume University School of Medicine, Fukuoka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ogata
authors.affiliation: Department of Surgery, Hokkaido Sapporo Kosei Hospital, Sapporo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Masuko
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, Osaka, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Maeda
authors.affiliation: Department of Gastrointestinal Surgery Kansai Medical University Hirakata Hospital, Osaka, Japan, Hiroshima, Japan.
authors.forename: Madoka
authors.initials: M
authors.lastname: Hamada
authors.affiliation: Department of Surgery 2, Tokyo Women's Medical College, Tokyo, Japan.
authors.forename: Michio
authors.initials: M
authors.lastname: Itabashi
authors.affiliation: Department of Surgery, Japanese Red Cross Kanazawa Hospital, Kanazawa, Japan.
authors.forename: Genichi
authors.initials: G
authors.lastname: Nishimura
authors.affiliation: Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: National Hospital Organization, Osaka National Hospital, Osaka, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Ikeda
authors.affiliation: Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Taguri
authors.affiliation: Nerima General Hospital, Tokyo, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Kodaira
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D015179:Colorectal Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011446:Prospective Studies; D012307:Risk Factors; D015983:Selection Bias; D005641:Tegafur / Q000008:administration & dosage; D014498:Uracil / Q000008:administration & dosage
chemical_list: D005641:Tegafur; D014498:Uracil; D002955:Leucovorin
keywords: Adjuvant chemotherapy; High-risk stage II; Propensity score matching; Treatment duration; UFT/Leucovorin