title: ESOPEC: prospective randomized controlled multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (NCT02509286).
abstract: Recent randomized controlled trials comparing neoadjuvant chemoradiation plus surgery or perioperative chemotherapy plus surgery with surgery alone showed significant survival benefits for combined modality treatment of patients with localized esophageal adenocarcinoma. However, head-to-head comparisons of neoadjuvant chemoradiation and perioperative chemotherapy applying contemporary treatment protocols are lacking. The present trial was initiated to obtain valid information whether neoadjuvant chemoradiation or perioperative chemotherapy yields better survival in the treatment of localized esophageal adenocarcinoma.
  
  
  
  The ESOPEC trial is an investigator-initiated multicenter prospective randomized controlled two-arm trial, comparing the efficacy of neoadjuvant chemoradiation (CROSS protocol: 41.4Gy plus carboplatin/paclitaxel) followed by surgery versus perioperative chemotherapy and surgery (FLOT protocol: 5-FU/leucovorin/oxaliplatin/docetaxel) for the curative treatment of localized esophageal adenocarcinoma. Patients with cT1cN + cM0 and cT2-4acNxcM0 esophageal and junctional adenocarcinoma are eligible. The trial aims to include 438 participants who are centrally randomized to one of the two treatment groups in a 1:1 ratio stratified by N-stage and study site. The primary endpoint of the trial is overall survival assessed with a minimum follow-up of 36 months. Secondary objectives are progression-free survival, recurrence-free survival, site of failure, postoperative morbidity and mortality, duration of hospitalization as well as quality of life.
  
  
  
  The ESOPEC trial compares perioperative chemotherapy according to the FLOT protocol to neoadjuvant chemoradiation according to the CROSS protocol in multimodal treatment of non-metastasized recectable adenocarcinoma of the esophagus and the gastroesophageal junction. The goal of the trial is identify the superior protocol with regard to patient survival, treatment morbidity and quality of life.
  
  
  
  NCT02509286 (July 22, 2015).
authors.affiliation: Department of General and Visceral Surgery, Medical Center - University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany. jens.hoeppner@uniklinik-freiburg.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Hoeppner
authors.affiliation: University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Lordick
authors.affiliation: Department of Radiation Oncology, Medical Center - University of Freiburg, Freiburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Brunner
authors.affiliation: Department of General and Visceral Surgery, Medical Center - University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.
authors.forename: Torben
authors.initials: T
authors.lastname: Glatz
authors.affiliation: Institute for Surgical Pathology, Medical Center - University of Freiburg, Freiburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bronsert
authors.affiliation: Clinical Trials Center, Medical Center - University of Freiburg, Freiburg, Germany.
authors.forename: Nadine
authors.initials: N
authors.lastname: Röthling
authors.affiliation: Clinical Trials Center, Medical Center - University of Freiburg, Freiburg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Schmoor
authors.affiliation: Department of Surgery, Sana Medical Center Offenbach, Offenbach, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Lorenz
authors.affiliation: Department of Gastroenterology, Sana Medical Center Offenbach, Offenbach, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ell
authors.affiliation: Department of General and Visceral Surgery, Medical Center - University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.
authors.forename: Ulrich T
authors.initials: UT
authors.lastname: Hopt
authors.affiliation: Medical Center, University of Freiburg, Freiburg, Germany.
authors.forename: J Rüdiger
authors.initials: JR
authors.lastname: Siewert
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D059248:Chemoradiotherapy / Q000379:methods; D018572:Disease-Free Survival; D004358:Drug Therapy / Q000379:methods; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000601:surgery / Q000628:therapy*; D004947:Esophagus / Q000187:drug effects / Q000528:radiation effects / Q000601:surgery; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D011788:Quality of Life; D011878:Radiotherapy / Q000379:methods; D016896:Treatment Outcome
keywords: Adenocarcinoma; Esophageal cancer; Neoadjuvant chemoradiation; Perioperative chemotherapy