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).
It is a prospective open-label randomized phase III clinical trial sponsored by N.N. Blokhin NMRC of Oncology. 156 patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0M0, cT1-4aN1-3M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (nCRT) followed by esophagectomy and the neoadjuvant chemotherapy group (nCT) followed by esophagectomy according to the proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are compared between the two regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Patients undergoing neoadjuvant chemoradiotherapy plus Ivory-Lewis or McKeown esophagectomy.
Patients undergoing neoadjuvant chemotherapy plus Ivory-Lewis or McKeown esophagectomy
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia
RECRUITINGDisease-free survival
Survival without local or systemic recurrence
Time frame: 3(5) years after last patient enrolled
Overall survival
Overall survival of patients
Time frame: 3(5) years after last patient enrolled
Treatment related complications
Сomplications after treatment
Time frame: During the procedure
Number of cycles, frequency of neoadjuvant therapy reduction
Number of chemotherapy/chemoradiotherapy cycles and doses and dose reductions
Time frame: During the procedure
Correlation between genetic profile and tumor response
Influence of the genetic profile on the tumor response
Time frame: Immediately after the procedure
Pathological response rate(pCR)
Frequency of pathological pathomorphosis
Time frame: Immediately after the surgery
R0 resection rate
Residual tumor rate
Time frame: Immediately after the surgery
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