OncoMatch/Clinical Trials/NCT06161818
Total Neoadjuvant Therapy for Lymph Node-positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction
Is NCT06161818 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies FLOT-CROSS or CROSS-FLOT for esophageal cancer.
Treatment: FLOT-CROSS or CROSS-FLOT — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Excluded: DPYD homozygous genotype (*2a, *13, 2846a>t, and 1236g>a)
Disease stage
Excluded: Stage OVERT HEMATOGENOUS (ORGAN) METASTASIS, DISTANT LYMPHATIC METASTASES (CERVICAL/RETROPERITONEAL), PERITONEAL OR PLEURAL DISSEMINATION
cT2-4aN+M0 resectable adenocarcinoma of the oesophagus or EGJ (Siewert type I-II) according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic chemotherapy
No prior cytotoxic chemotherapy for oesophageal cancer
Cannot have received: radiation therapy
Exception: no prior abdominal, thoracic or cervical radiotherapy overlapping with the CROSS irradiation fields
No prior abdominal, thoracic or cervical radiotherapy overlapping with the CROSS irradiation fields
Lab requirements
Blood counts
White Blood Cells >3x10^9/L; Haemoglobin >5.5 mmol/L; platelets >100x10^9/L; last red blood cell transfusion >2 weeks before inclusion
Kidney function
GFR >50 ml/min or serum creatinine ≤1.5 x ULN
Liver function
total bilirubin <1.5x ULN; AST <2.5x ULN; ALT <3x ULN
Cardiac function
adequate cardiac function (cardiac function tests only necessary in symptomatic patients)
Adequate cardiac and respiratory function ... Adequate bone marrow function (White Blood Cells >3x10^9/L; Haemoglobin >5.5 mmol/L; platelets >100x10^9/L). In the event of transfusions, the last red blood cell transfusion should be more than 2 weeks before inclusion. Adequate renal function (Glomerular Filtration Rate >50 ml/min) or serum creatinine ≤1.5 x upper limit of normal (ULN) and adequate liver function (total bilirubin <1.5x Upper Level of Normal (ULN); Aspartate transaminase (AST) <2.5x ULN and Alanine transaminase (ALT) <3x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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