Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial
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).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall 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
No
People's Republic of China: State Food and Drug Administration
2011ESO_FU_02
NCT01398449
April 2011
December 2017
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