A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any N, M0).
Patient Population: Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging. T3-4, any N, M0. Scheme: 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: Arm A: Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy (4 cycles). Arm B: Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
In Arm B, postsurgical radiation target volume includes tumor bed only
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGSurvival
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.
Safety and Tolerability
To evaluate the incidence rate of adverse events-especially radiation-induced lung toxicity
Failure pattern
To evaluate the rationality of radiation target volumes by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences.
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