title: GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study.
abstract: BACKGROUND
  In Europe, gastric cancer remains diagnosed at advanced stage (serosal and/or lymph node involvement). Despite curative management combining perioperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates of T3 and/or N + patients remain under 30%. More than 50% of recurrences are peritoneal and/or locoregional. The use of adjuvant hyperthermic intraperitoneal chemotherapy that eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences, was extensively evaluated by several randomized trials conducted in Asia. Two meta-analysis reported that adjuvant hyperthermic intraperitoneal chemotherapy significantly reduces the peritoneal recurrences and significantly improves the overall survival. As it was previously done for the evaluation of the extension of lymph node dissection, it seems very important to validate on European or caucasian patients the results observed in trials performed in Asia.
  
  
  METHODS
  GASTRICHIP is a prospective, open, randomized multicenter phase III clinical study with two arms that aims to evaluate the effects of hyperthermic intraperitoneal chemotherapy with oxaliplatin on patients with gastric cancer involving the serosa and/or lymph node involvement and/or with positive cytology at peritoneal washing, treated with perioperative systemic chemotherapy and D1-D2 curative gastrectomy. Peroperatively, at the end of curative surgery, patients will be randomized after preoperatively written consent has been given for participation. Primary endpoint will be overall survival from the date of surgery to the date of death or to the end of follow-up (5 years). Secondary endpoint will be 3- and 5-year recurrence-free survival, site of recurrence, morbidity, and quality of life. An ancillary study will compare the incidence of positive peritoneal cytology pre- and post-gastrectomy in two arms of the study, and assess its impact on 5-year survival. The number of patients to be randomized was calculated to be 306.
  
  
  BACKGROUND
  EudraCT number: 2012-005748-12, ClinicalTrials.gov identifier: NCT01882933.
authors.affiliation: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Service de Chirurgie Viscérale et Endocrinienne, Pierre-Bénite Cedex 69495, France. olivier.glehen@chu-lyon.fr.
authors.forename: Olivier
authors.initials: O
authors.lastname: Glehen
authors.forename: Guillaume
authors.initials: G
authors.lastname: Passot
authors.forename: Laurent
authors.initials: L
authors.lastname: Villeneuve
authors.forename: Delphine
authors.initials: D
authors.lastname: Vaudoyer
authors.forename: Sylvie
authors.initials: S
authors.lastname: Bin-Dorel
authors.forename: Gilles
authors.initials: G
authors.lastname: Boschetti
authors.forename: Eric
authors.initials: E
authors.lastname: Piaton
authors.forename: Alfredo
authors.initials: A
authors.lastname: Garofalo
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005060:Europe; D005743:Gastrectomy / Q000379:methods; D006801:Humans; D006979:Hyperthermia, Induced; D008197:Lymph Node Excision / Q000379:methods; D008207:Lymphatic Metastasis / Q000473:pathology*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000556:secondary / Q000628:therapy*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology* / Q000628:therapy*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin