A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes
removed for adequate nodal staging.
T3-4, any N, M0.
After esophagectomy, patients are firstly stratified by 2 factors: (1)number of lymph node
metastasis (<3 or >=3) and (2)tumor resection status (R1 resection or R2 resection).
Note: Pathological R0 resection status is required for this study. So here R1 and R2
resection are not actually pathological status of resection, only clinical judgement by
physician based on the chest-CT before esophagectomy.
Then patients are randomized to 2 arms:
Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential
chemotherapy (4 cycles).
Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate if the survival outcome of postsurgical radiation with a small target volume involved tumor bed only is not worse than a large volume (tumor bed and elective nodes) for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.
Xiao-Long Fu, M.D, Ph.D.
People's Republic of China: State Food and Drug Administration