Background: Neoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous\ncell carcinoma due to its significant postoperative mortality. However, it is assumed the combination of neoadjuvant\nchemoradiation with minimally invasive esophagectomy (MIE) may reduce postoperative mortality, which can revive\npreoperative chemoradiation. No randomized controlled studies comparing neoadjuvant chemoradiation plus MIE with\nneoadjuvant chemotherapy plus MIE have been performed so far. The present trial is initiated to obtain valid information\nwhether neoadjuvant chemoradiation plus MIE yields better survival without worse postoperative morbidity and mortality\nin the treatment of locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).\nMethods/design: CMISG1701 is a multicenter, prospective, randomized, phase III clinical trial, investigating the safety and\nefficacy of neoadjuvant chemoradiation plus MIE compared with neoadjuvant chemotherapy plus MIE. Patients with\nlocally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0-1M0) are eligible for the study. A total of 264\npatients are randomly assigned to neoadjuvant chemoradiation (arm A) or neoadjuvant chemotherapy (arm B) with a 1:1\nallocation ratio. The primary outcome is overall survival assessed with a minimum follow-up of 36 months. Secondary\noutcomes are progression-free survival, recurrence-free survival, postoperative pathologic stage, treatment-related\ncomplications, postoperative mortality as well as quality of life.\nDiscussion: The objective of this trial is to identify the superior protocol with regard to patient survival, treatment\nmorbidity/mortality and quality of life between neoadjuvant chemoradiation plus MIE and neoadjuvant chemotherapy\nplus MIE.
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