Perioperative Chemotherapy (FLOT Protocol) Compared with Neoadjuvant Chemoradiation (CROSS Protocol) in Patients with Adenocarcinoma of the Esophagus (ESOPEC)

• Applicant: Professor Dr. Jens Höppner
• Subject Area: General and Visceral Surgery
• Term: since 2015
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 264590883

The ESOFU study presented here is a prospective, longitudinal observational study based on the ESOPEC study already funded by the DFG. The ESOPEC data presented at ASCO 2024 (Chicago, USA) demonstrated the superiority of perioperative chemotherapy analogous to the FLOT regimen in combination with surgical resection of esophageal adenocarcinoma over neoadjuvant chemoradiation analogous to CROSS including resection in terms of short-term overall survival (data accepted for publication in NEJM). The ESOFU study will follow ESOPEC patients who are still alive for up to a total of 10 years (follow-up period per patient: 36 - 86 months). The study endpoints include overall survival, progression-free survival, localization of possible tumor progression/recurrence, and recurrence-free survival. Currently, 143 living patients (out of 438 patients initially enrolled) from a total of 22 participating centers are still eligible for inclusion in the ESOFU study (formal inclusion criteria): Participation in the ESOPEC study with the associated inclusion criteria at that time, consent to long-term observation and ability to understand the scope of participation). Once the total study duration of 90 months has been reached, the statistical analysis of the parameters mentioned above will be performed by the Clinical Study Department of the University Medical Center Freiburg. Finally, publication of the ESOFU study data is planned.

• DFG Programme: Clinical Trials
• Co-Investigator: Privatdozent Dr. Patrick Sven Plum