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

NCT06161818 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer
  • Adenocarcinoma of the Esophagus

Interventions

DRUG

FLOT-CROSS or CROSS-FLOT

Randomization between TNT FLOT-CROSS and TNT CROSS-FLOT

Sponsors & Collaborators

Principal Investigators

  • Bianca Mostert, MD, PhD · Erasmus Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-12
Primary Completion
2029-09-01
Completion
2029-12-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161818 on ClinicalTrials.gov