title: Phase 3 trial of postoperative chemotherapy alone versus chemoradiation therapy in stage III-IV gastric cancer treated with R0 gastrectomy and D2 lymph node dissection.
abstract: OBJECTIVE
  To compare chemotherapy alone with chemoradiation therapy in stage III-IV(M0) gastric cancer treated with R0 gastrectomy and D2 lymph node dissection.
  
  
  METHODS
  The chemotherapy arm received 5 cycles of fluorouracil and leucovorin (FL), and the chemoradiation therapy arm received 1 cycle of FL, then radiation therapy of 45 Gy concurrently with 2 cycles of FL, followed by 2 cycles of FL. Intent-to-treat analysis and per-protocol analyses were performed.
  
  
  RESULTS
  Between May 6, 2002 and June 29, 2006, a total of 90 patients were enrolled. Forty-four were randomly assigned to the chemotherapy arm and 46 to the chemoradiation therapy arm. Treatment was completed as planned by 93.2% of patients in the chemotherapy arm and 87.0% in the chemoradiation therapy arm. Overall intent-to-treat analysis showed that addition of radiation therapy to chemotherapy significantly improved locoregional recurrence-free survival (LRRFS) but not disease-free survival. In subgroup analysis for stage III, chemoradiation therapy significantly prolonged the 5-year LRRFS and disease-free survival rates compared with chemotherapy (93.2% vs 66.8%, P=.014; 73.5% vs 54.6%, P=.056, respectively).
  
  
  CONCLUSIONS
  Addition of radiation therapy to chemotherapy could improve the LRRFS in stage III gastric cancer treated with R0 gastrectomy and D2 lymph node dissection.
authors.affiliation: Research Institute and Hospital, National Cancer Center, Goyang, Korea.
authors.forename: Tae Hyun
authors.initials: TH
authors.lastname: Kim
authors.forename: Sook Ryun
authors.initials: SR
authors.lastname: Park
authors.forename: Keun Won
authors.initials: KW
authors.lastname: Ryu
authors.forename: Young-Woo
authors.initials: YW
authors.lastname: Kim
authors.forename: Jae-Moon
authors.initials: JM
authors.lastname: Bae
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Lee
authors.forename: Il Ju
authors.initials: IJ
authors.lastname: Choi
authors.forename: Yeon-Joo
authors.initials: YJ
authors.lastname: Kim
authors.forename: Dae Yong
authors.initials: DY
authors.lastname: Kim
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality; D009367:Neoplasm Staging; D011184:Postoperative Period; D011879:Radiotherapy Dosage; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*
chemical_list: D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil