title: Feasibility of preoperative and postoperative chemoradiotherapy in gastric adenocarcinoma. Two phase II studies done in parallel. Fédération Francophone de Cancérologie Digestive 0308.
abstract: BACKGROUND
  For resectable gastric cancer, both postoperative chemoradiotherapy and perioperative chemotherapy demonstrate high-level evidence for improved survival in Western populations. To evaluate the feasibility of pre- or postoperative chemoradiotherapy, we proposed two multicentre phase II studies.
  
  
  METHODS
  Patients with localised, histologically confirmed gastric cancer and Eastern Cooperative Oncology Group (ECOG) performance status <2 judged suitable for curative resection were eligible. Eligible patients were assigned to either preoperative chemoradiotherapy followed by surgical resection or surgical resection followed by chemoradiotherapy depending on each centre. Chemoradiotherapy regimen included four courses of FOLFIRI (5 Fluorouracil, Leucovorin, Irinotecan) regimen then Concurrent fluorouracil at 200 mg/m2/d by continuous infusion 5 days each week. A dose of 50 Gy in 25 fractions in the preoperative study, or 45 Gy in 25 fractions in the postoperative study, was delivered. The primary end-point for both studies was the proportion of patients, who completed the therapeutic sequence.
  
  
  RESULTS
  Between September 2007 and January 2010, 63 patients were included in both studies. The postoperative study was stopped for futility at the first step. In the preoperative study, 31 patients (73.8%, confidence interval (CI) 95%: 65.8-90.1%) received complete therapeutic sequence. Serum albumin and dietary restriction evaluated by QLQ-STO22 (Quality of Life-Stomach module) score were significantly linked with chemoradiotherapy feasibility in univariate analysis with respectively Odds-ratio (OR) 1.16 [CI 95%: 1.01-1.33] and 0.17 [0.03-0.89], p=0.04. Median overall survival time was 26.4 months in the preoperative study.
  
  
  CONCLUSIONS
  Feasibility of chemoradiotherapy was not achieved for these studies: 73.8% (CI 95%: 65.8-90.1) and 42.9% (CI 95%: 21.8-66%) in preoperative and postoperative settings respectively.
authors.affiliation: Department of Gastroenterology, Rouen University Hospital, University of Rouen, 1 rue de Germont, 76031 Rouen, France. Electronic address: Pierre.michel@chu-rouen.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: Michel
authors.affiliation: Centre Hospitalier Colmar, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Breysacher
authors.affiliation: Centre Hospitalo-Universitaire Lyon Sud, Pierre Bénite, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Mornex
authors.affiliation: Assistance Publique-hopitaux de Marseille, hopital Timone, France.
authors.forename: Jean François
authors.initials: JF
authors.lastname: Seitz
authors.affiliation: Centre Hospitalo-Universitaire Lyon Croix Rousse, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Pere-Verge
authors.affiliation: Centre de Lutte Contre le Cancer de Lyon, Leon Berard, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Martel-Lafay
authors.affiliation: Centre Hospitalier La Roche sur Yon, France.
authors.forename: Roger
authors.initials: R
authors.lastname: Faroux
authors.affiliation: Centre Hospitalo-Universitaire, Tours, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Chapet
authors.affiliation: Assistance Publique-hopitaux de Paris, Centre Hospitalo-Universitaire, Creteil, France.
authors.forename: Iradj
authors.initials: I
authors.lastname: Sobhani
authors.affiliation: Centre Hospitalo-Universitaire, Clermont Ferrand, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Pezet
authors.affiliation: Assistance Publique-hopitaux de Paris, Centre Hospitalo-Universitaire, Bichat, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Aparicio
authors.affiliation: Centre Hospitalier, Beauvais, France.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Nguyen
authors.affiliation: Assistance Publique-hopitaux de Paris, Centre Hospitalo-Universitaire, Cochin, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Dousset
authors.affiliation: Centre Hospitalo-Universitaire, Dijon, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Jouve
authors.affiliation: Fédération Francophone de Cancérologie Digestive, France.
authors.forename: Emilie
authors.initials: E
authors.lastname: Maillard
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D059248:Chemoradiotherapy; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011184:Postoperative Period; D057234:Preoperative Period; D013270:Stomach / Q000187:drug effects / Q000528:radiation effects / Q000601:surgery; D013274:Stomach Neoplasms / Q000601:surgery / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: Adjuvant treatment; Chemo radiotherapy; Gastric cancer