Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction
TNT-OES-2
Sponsor study identifier
Secondary identifiers
CTIS
NIH
interventional
216
1 country
10
Study Start
September 12, 2025
Actual (reported)Primary Completion
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2023
Actual (reported)December 8, 2023
Actual (reported)September 12, 2025
Actual (reported)September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-free survival
To determine the progression-free survival (PFS) after TNT (both FLOT-CROSS and CROSS-FLOT), the PFS is defined as the time interval from randomization to the first event of locoregional failure after surgery, or locoregional progression leading to irresectability prior to surgery , progression to metastatic disease or death
24 months
Feasibility, completion of treatment
30 months
Overall survival
24 months
Patients allocated to the TNT FLOT-CROSS arm will be treated with 4 cycles of FLOT chemotherapy followed by a response evaluation consisting of a CT-scan and upper endoscopy with bite-on-bite biopsies of the primary tumor site and of any other suspected lesions in the esophagus. Patients with distant metastases will go off-study. All other patients will proceed to CROSS chemoradiotherapy.
Patients allocated to the TNT CROSS-FLOT arm will be treated with CROSS chemoradiotherapy followed by a response evaluation consisting of a CT-scan and upper endoscopy with bite-on-bite biopsies of the primary tumor site and of any other suspected lesions in the esophagus. Patients with distant metastases will go off-study. All other patients will proceed to FLOT chemotherapy.
Randomization between TNT FLOT-CROSS and TNT CROSS-FLOT
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Folinezuur Kalceks 10 mg/ml oplossing voor injectie/infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Docetaxel Eugia 20 mg/ml, concentraat voor oplossing voor intraveneuze infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Folinezuur Kalceks 10 mg/ml oplossing voor injectie/infusie
Named ingredient: Folinic Acid
View registry recordPaclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie
Named ingredient: Paclitaxel
View registry recordCarboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie
Named ingredient: Carboplatin
View registry recordDocetaxel Eugia 20 mg/ml, concentraat voor oplossing voor intraveneuze infusie
Named ingredient: Docetaxel
View registry recordFluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie
Named ingredient: Fluorouracil
View registry recordOxaliplatine Fresenius Kabi 5 mg/ml concentraat voor oplossing voor infusie
Named ingredient: Oxaliplatin
View registry recordCatharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Frisius medisch centrum
Leeuwarden, North Brabant, Netherlands
van der Zijden CJ, Eyck BM, van der Gaast A, van Doorn L, Nuyttens JJME, van Lanschot JJB, Wijnhoven BPL, Mostert B, Lagarde SM. Chemotherapy aNd chemoradiotherapy for adenocarcinoma of the OESophagus and esophagogastric junction with oligometastases: Protocol of the TNT-OES-1 trial. Contemp Clin Trials Commun. 2022 May 28;28:100934. doi: 10.1016/j.conctc.2022.100934. eCollection 2022 Aug.
Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
Bianca Mostert, MD, PhD
Erasmus Medical Centre
First Submitted
November 9, 2023
First Posted
December 8, 2023
Study Start
September 12, 2025
Actual (reported)Primary Completion
September 1, 2029
Therapy-related toxicity
30 months
Dose reductions of TNT
30 months
Need of G-CSF
60 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Formulated product
Fluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
Oxaliplatine Fresenius Kabi 5 mg/ml concentraat voor oplossing voor infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordContact the study team to confirm eligibility.
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
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 22, 2025
Record last verified: 2025-12
Study fields come from the primary record; confirmed relationships can use other sources. Selecting a record here changes its provenance and downloads, without replacing the displayed study fields.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: