A randomized phase II tials to study whether it's benefit of adding Nimotuzumab to chemoradiation for patients with esophageal squamous cell carcinoma after radical esophagectomy who suffer with locoregional lymph nodes recurrence.
Patient population: Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy. Scheme: Eligible recurrent patients with esophageal cancer will first be stratified by recurrent time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after esophagectomy), then randomized to 2 arms at 1:1 ratio. Arm A: Chemoradiation + weekly Nimotuzumab for 6 weeks concurrent with radiation. Arm B: Chemoradiation only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGLocal control
To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
Overall survival
To evaluate if the addition of nimotuzumab to chemoradiation improves overall survival compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
Adverse Events
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