RecruitingPhase 2NCT06161818

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

Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction: a Phase II Study


Sponsor

Erasmus Medical Center

Enrollment

216 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a "total neoadjuvant therapy" (TNT) approach — giving chemotherapy and radiation before surgery — for people with lymph node-positive rectal cancer that has spread to the area just above the rectum. TNT aims to shrink the tumor as much as possible before surgery to improve outcomes. **You may be eligible if...** - You are 18–75 years old with rectal cancer (adenocarcinoma) - Your cancer is confirmed to have positive lymph nodes in the perirectal region - You have not had prior treatment for this cancer - Your general health allows you to tolerate chemotherapy and radiation **You may NOT be eligible if...** - Your cancer has spread to distant organs (Stage IV) - You have had prior pelvic radiation - You have serious heart, kidney, liver, or lung disease - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (some exceptions apply) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFLOT-CROSS or CROSS-FLOT

Randomization between TNT FLOT-CROSS and TNT CROSS-FLOT


Locations(10)

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Frisius medisch centrum

Leeuwarden, North Brabant, Netherlands

Elisabeth Tweesteden Ziekenhuis

Tilburg, North Brabant, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Erasmus Medical Centre

Rotterdam, South Holland, Netherlands

Ziekenhuisgroep Twente

Almelo, Netherlands

Antoni van Leeuwenhoek/Nederlands Kanker Instituut

Amsterdam, Netherlands

Gelre ziekenhuis

Apeldoorn, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06161818


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