Clinical Trial

Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction

Study acronym: TNT-OES-2
Recruiting Phase 2
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Summary
Both neoadjuvant chemoradiotherapy (CROSS) and neoadjuvant chemotherapy (FLOT) have demonstrated overall survival benefit over surgery alone in esophageal and esophagogastric junction (EGJ) cancer. Despite these survival gains, the prognosis remains poor, especially in patients with nodal-positive adenocarcinoma (cN+ AC) (5-year survival 36%, compared to 55% for cN0). This highlights the need for more effective treatment options, and justifies treatment intensification in these patients. The aim of this study is to determine the efficacy and feasibility of TNT FLOT-CROSS and TNT CROSS-FLOT in patients with resectable, cN+ AC of the esophagus or EGJ.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-29; most recent amendment 2025-12-16.
Status change: Not Yet Recruiting → Recruiting 2025-12-16
Trial Details
NCT Number NCT06161818
Lead Sponsor Erasmus Medical Center
Conditions Esophageal Cancer, Adenocarcinoma of the Esophagus
Enrollment 216 participants
Start Date 2025-09-12
Primary Completion 2029-09-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-22