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).
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
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 malignant disease.
Parallel
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Procedure/SurgeryPatients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Procedure/SurgeryPatients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
Disease-free survival
Survival without local or systemic recurrence
Overall survival
Overall survival of patients
Treatment related complications
Сomplications after treatment
Number of cycles, frequency of neoadjuvant therapy reduction
Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions
Correlation between genetic profile and tumor response
Influence of the genetic profile on the tumor response
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