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

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

Trial Details

NCT ID
NCT06161818
Phase
PHASE2
Sponsor
Erasmus Medical Center
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • FLOT-CROSS or CROSS-FLOT
Locations (sample)
  • Eindhoven, North Brabant, Netherlands|51.44083,5.47778
  • Leeuwarden, North Brabant, Netherlands
  • Tilburg, North Brabant, Netherlands|51.55551,5.0913
  • Amsterdam, North Holland, Netherlands|52.37403,4.88969
  • Rotterdam, South Holland, Netherlands|51.9225,4.47917

Key Eligibility Criteria

  • Patients with cT2-4aN+M0 resectable adenocarcinoma of the oesophagus or EGJ (Siewert type I-II) according to the 8th edition of the Union for Inter…
  • Clinical N+ status should be determined by EUS or 18F-FDG PET/CT. Clinical M0 status must be determined by 18F-FDG PET/CT.
  • Maximum of 4 cm ingrowth in the cardia, measured by upper endoscopy.
  • In case of tumor and/or lymph node involvement below the diaphragm, the most proximal involved lymph node station cannot be higher than N7 (Appendi…

For full eligibility, visit ClinicalTrials.gov.

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