title: Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS).
abstract: BACKGROUND
  Radical surgery is the cornerstone in the treatment of resectable gastric cancer. The Intergroup 0116 and MAGIC trials have shown benefit of postoperative chemoradiation and perioperative chemotherapy, respectively. Since these trials cannot be compared directly, both regimens are evaluated prospectively in the CRITICS trial. This study aims to obtain an improved overall survival for patients treated with preoperative chemotherapy and surgery by incorporating radiotherapy concurrently with chemotherapy postoperatively.
  
  
  METHODS
  In this phase III multicentre study, patients with resectable gastric cancer are treated with three cycles of preoperative ECC (epirubicin, cisplatin and capecitabine), followed by surgery with adequate lymph node dissection, and then either another three cycles of ECC or concurrent chemoradiation (45 Gy, cisplatin and capecitabine). Surgical, pathological, and radiotherapeutic quality control is performed. The primary endpoint is overall survival, secondary endpoints are disease-free survival (DFS), toxicity, health-related quality of life (HRQL), prediction of response, and recurrence risk assessed by genomic and expression profiling. Accrual for the CRITICS trial is from the Netherlands, Sweden, and Denmark, and more countries are invited to participate.
  
  
  CONCLUSIONS
  Results of this study will demonstrate whether the combination of preoperative chemotherapy and postoperative chemoradiotherapy will improve the clinical outcome of the current European standard of perioperative chemotherapy, and will therefore play a key role in the future management of patients with resectable gastric cancer.
  
  
  BACKGROUND
  clinicaltrials.gov NCT00407186.
authors.affiliation: Department of Surgery, K6-R, Leiden University Medical Center, P.O. Box9600, 2300 RC Leiden, The Netherlands.
authors.forename: Johan L
authors.initials: JL
authors.lastname: Dikken
authors.forename: Johanna W
authors.initials: JW
authors.lastname: van Sandick
authors.forename: H A
authors.initials: HA
authors.lastname: Maurits Swellengrebel
authors.forename: Pehr A
authors.initials: PA
authors.lastname: Lind
authors.forename: Hein
authors.initials: H
authors.lastname: Putter
authors.forename: Edwin P M
authors.initials: EP
authors.lastname: Jansen
authors.forename: Henk
authors.initials: H
authors.lastname: Boot
authors.forename: Nicole C T
authors.initials: NC
authors.lastname: van Grieken
authors.forename: Cornelis J H
authors.initials: CJ
authors.lastname: van de Velde
authors.forename: Marcel
authors.initials: M
authors.lastname: Verheij
authors.forename: Annemieke
authors.initials: A
authors.lastname: Cats
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D059186:Chemoradiotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D020360:Neoadjuvant Therapy; D012107:Research Design; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil