Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?
Patient Population: Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging. R0 resection; T1-2, N+, M0. Scheme: After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (\<3 or \>=3). Then patients are randomized to 2 arms: Arm A: Adjuvant chemotherapy (4 cycles). Arm B: Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
874
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGOverall survival
To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0
Locoregional control rate
Safety and Tolerability (incidence rate of adverse events)
the incidence rate of adverse events, especially radiation-induced lung toxicity
Failure pattern
To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences
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