Actively Recruiting
Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction
Led by Erasmus Medical Center · Updated on 2025-12-22
216
Participants Needed
10
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cT2-4aN+M0 resectable adenocarcinoma of the esophagus or esophagogastric junction (Siewert type I-II) planned for neoadjuvant chemoradiotherapy or chemotherapy
- Clinical nodal-positive status determined by EUS or PET/CT and no distant metastasis
- Tumor invasion into the cardia maximum 4 cm measured by endoscopy
- Lymph node involvement limited to specific regions as defined by protocol
- Age 18 years or older; geriatric assessment required for patients 70 years or older with low G8 score
- No prior overlapping radiotherapy or cytotoxic chemotherapy for esophageal cancer
- ECOG Performance Status 0-1
- Weight loss less than 10%
- Adequate cardiac, respiratory, bone marrow, renal, and liver function
- Negative pregnancy test for women of child-bearing potential
- Use of adequate contraception during and up to 3 months after study
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Tumors of squamous, adenosquamous, or other non-adenocarcinoma histology
- Eligibility or participation in the TRAP-2 trial (NCT05188313)
- Presence of distant organ or lymphatic metastases, peritoneal or pleural spread
- Clinically significant active cardiac or lung disease
- Peripheral neuropathy greater than grade 1
- Homozygous DPYD genotype for specific variants
- Pregnancy, lactation, or lack of effective contraception
- Other active malignancies with interfering prognosis
- Expected non-compliance with the study protocol
- Limitations impairing understanding or informed consent such as language barrier or dementia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Not Yet Recruiting
2
Frisius medisch centrum
Leeuwarden, North Brabant, Netherlands
Not Yet Recruiting
3
Elisabeth Tweesteden Ziekenhuis
Tilburg, North Brabant, Netherlands
Not Yet Recruiting
4
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Not Yet Recruiting
5
Erasmus Medical Centre
Rotterdam, South Holland, Netherlands
Actively Recruiting
6
Ziekenhuisgroep Twente
Almelo, Netherlands
Not Yet Recruiting
7
Antoni van Leeuwenhoek/Nederlands Kanker Instituut
Amsterdam, Netherlands
Not Yet Recruiting
8
Gelre ziekenhuis
Apeldoorn, Netherlands
Not Yet Recruiting
9
Leids Universitair Medisch Centrum
Leiden, Netherlands
Not Yet Recruiting
10
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Not Yet Recruiting
Research Team
B
Bianca Mostert, MD, PhD
CONTACT
E
Esmee A de Bruijn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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