This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Chemoradiotherapy
National Cancer Center Hospital
Tokyo, Japan
RECRUITINGMajor progression-free survival
If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events.
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.
Overall survival
From date of randomization to date of death, approximately 5 years.
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.
Progression-free survival
From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.
Complete response rate
CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.
Esophagectomy-free survival
From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.
Adverse events
Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.
Long term toxicity
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Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0
Time frame: The primary analysis will be held 5-years after the last patient was enrolled.