title: A randomized multicenter trial comparing resection and radiochemotherapy for resectable locally invasive pancreatic cancer.
abstract: BACKGROUND
  Though the outcome of resection for locally invasive pancreatic cancer is still poor, it has gradually improved in Japan, and the 5-year survival is now about 10%. However, the advantage of resection over radiochemotherapy has not yet been confirmed by a randomized trial. We conducted this study to compare surgical resection alone versus radiochemotherapy without resection for locally invasive pancreatic cancer using a multicenter randomized design.
  
  
  METHODS
  Patients with pancreatic cancer who met our preoperative criteria for inclusion (pancreatic cancer invading the pancreatic capsule without involvement of the superior mesenteric artery or the common hepatic artery, or without distant metastasis) underwent laparotomy. Patients with operative findings consistent with our criteria were randomized into a radical resection group and a radiochemotherapy group (200 mg/m(2)/day of intravenous 5-fluorouracil and 5040 cGy of radiotherapy) without resection. The 2 groups were compared for mean survival, hazard ratio, 1-year survival, quality of life scores, and hematologic and blood chemical data.
  
  
  RESULTS
  Twenty patients were assigned to the resection group and 22 to the radiochemotherapy group. There was 1 operative death. The surgical resection group had better results than the radiochemotherapy group as measured by 1-year survival (62% vs 32 %, P=.05), mean survival time (>17 vs 11 months, P < .03), and hazard ratio (0.46, P=.04). There were no differences in the quality of life score or laboratory data apart from increased diarrhea after surgical resection.
  
  
  CONCLUSIONS
  Locally invasive pancreatic cancer without distant metastases and major arterial invasion appears to be best treated by surgical resection.
authors.affiliation: Department of Surgery and Surgical Basic Science, Kyoto University, Kyoto 606-8507, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Imamura
authors.forename: Ryuichiro
authors.initials: R
authors.lastname: Doi
authors.forename: Toshihide
authors.initials: T
authors.lastname: Imaizumi
authors.forename: Akihiro
authors.initials: A
authors.lastname: Funakoshi
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Wakasugi
authors.forename: Makoto
authors.initials: M
authors.lastname: Sunamura
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Ogata
authors.forename: Shoichi
authors.initials: S
authors.lastname: Hishinuma
authors.forename: Takehide
authors.initials: T
authors.lastname: Asano
authors.forename: Takashi
authors.initials: T
authors.lastname: Aikou
authors.forename: Ryo
authors.initials: R
authors.lastname: Hosotani
authors.forename: Shunzo
authors.initials: S
authors.lastname: Maetani
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D006801:Humans; D007564:Japan; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D011788:Quality of Life; D012727:Sex Characteristics; D016019:Survival Analysis; D013997:Time Factors