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

Study acronym: TNT-OES-2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Study sites: 0 to 10 · Start date changed from estimate of Jul 1, 2025 to Sep 12, 2025 · 4 morev3 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 10
    • Start date changed from estimate of Jul 1, 2025 to Sep 12, 2025
    • Eligibility criteria expanded, about 101 words
    • Secondary endpoints: 10 to 16
    • Study description revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jul 1, 2024 to Jul 1, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06161818
Lead Sponsor Erasmus Medical Center
Conditions Esophageal Cancer, Adenocarcinoma of the Esophagus
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov