The Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. This is non-inferiority study (neoadjuvant chemoradiotherapy has no advantage over neoadjuvant chemotherapy).
Eligibility Criteria
Inclusion Criteria: * Written informed consent. * Histologically confirmed squamous cell carcinoma of the esophagus. * Clinical stage cT1-4aN1-3M0 (AJCC/UICC 8th Edition). * Indications for surgical esophageal resection * ECOG status 0-1. * Adequate bone marrow function (White Blood Cells \> 3.0 x 109/L; Neutrophil \> 2.0 × 109/L; Hemoglobin \> 90 g/L; Platelets \> 100 x 109/L). * Adequate liver function (Total bilirubin \< 1.5 x Upper Level of Normal (ULN); Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 3.0 x ULN); * Adequate renal function (Glomerular filtration rate (CCr) \> 50 ml/min. * Adequate cardiac function. Left ventricular ejection fraction \> 50%. * Age from 18 years to 70 Exclusion Criteria: * Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition). * Patients with advanced non-operable or metastatic esophageal cancer. * Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy. * Patients with another previous or current ma