title: A randomized phase II/III trial comparing hepatectomy followed by mFOLFOX6 with hepatectomy alone as treatment for liver metastasis from colorectal cancer: Japan Clinical Oncology Group Study JCOG0603.
abstract: A randomized controlled trial is being conducted in Japan to compare hepatectomy alone with hepatectomy followed by adjuvant chemotherapy as treatment in patients with curatively resected liver metastases from colorectal cancer to improve survival with intensive chemotherapy. Between 42 and 70 days after liver resection, patients are randomly assigned to either hepatectomy alone or hepatectomy followed by 12 cycles of modified FOLFOX6 (mFOLFOX6) regimen. A total of 300 patients (including 78 patients in Phase II) will be accrued from 38 institutions within 3 years. The primary endpoint is treatment compliance at nine courses of mFOLFOX6 regimen in Phase II and disease-free survival in Phase III. The secondary endpoints are overall survival, incidence of adverse events and patterns of recurrence.
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. ykanemit@aichi-cc.jp
authors.forename: Yukihide
authors.initials: Y
authors.lastname: Kanemitsu
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Kato
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimizu
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Inaba
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Akihiro
authors.initials: A
authors.lastname: Sato
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Moriya
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006498:Hepatectomy; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000556:secondary* / Q000601:surgery; D008297:Male; D009361:Neoplasm Invasiveness; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil