title: Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2.
abstract: OBJECTIVE
  To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer, a multicenter phase III clinical trial was conducted in Japan.
  
  
  METHODS
  From January 1993 to March 1998, 268 patients were randomized to adjuvant chemotherapy (135 patients) or surgery alone (133 patients). All patients underwent gastrectomy with D2 or greater lymph node dissection. The chemotherapy regimen consisted of intraperitoneal cisplatin soon after abdominal closure, postoperative intravenous cisplatin (day 14) and 5-fluorouracil (day 14-16), and daily oral FU (UFT) starting 4 weeks after surgery for 12 months. The primary endpoint was overall survival. Relapse-free survival and site of recurrence were secondary endpoints.
  
  
  RESULTS
  Fifty-two patients (38.5%) in the adjuvant chemotherapy arm completed the chemotherapy regimen. There were 4 (1.49%) treatment-related deaths, 1 in the surgery-alone and 3 in the adjuvant chemotherapy arm (2 did not receive chemotherapy). Grade 4 toxicity was observed in 3 patients in the surgery-alone and 2 patients in the adjuvant chemotherapy arm. There was no significant difference in 5-year overall survival (62.0% adjuvant chemotherapy vs. 60.9% surgery-alone, P = 0.482) and 5-year relapse-free survival rates (57.5% adjuvant chemotherapy vs. 55.6% surgery-alone; P = 0.512).
  
  
  CONCLUSIONS
  There was no benefit in overall and relapse-free survival with this adjuvant chemotherapy regimen for patients with macroscopically serosa-positive gastric cancer after curative resection.
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. miyashir@biken.osaka-u.ac.jp
authors.forename: Isao
authors.initials: I
authors.lastname: Miyashiro
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nashimoto
authors.forename: Toshifusa
authors.initials: T
authors.lastname: Nakajima
authors.forename: Taira
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Osamu
authors.initials: O
authors.lastname: Kobayashi
authors.forename: Kuniyoshi
authors.initials: K
authors.lastname: Arai
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D015331:Cohort Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D007274:Injections, Intraperitoneal; D007275:Injections, Intravenous; D007564:Japan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012704:Serous Membrane / Q000187:drug effects / Q000473:pathology* / Q000601:surgery; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil