To investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy.
After completion of concurrent chemoradiotherapy, patients will be reassed and visited to multidisciplinary clinic, then, randomized to either observation or esophagectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
486
esophagectomy
Asan Medical Center
Seoul, South Korea
2-year disease-free survival (DFS) rate
Time frame: 2 years from the enrollment of last patient
Overall survival (OS)
Time frame: 5 years from the enrollment of last patient
progression-free survival
Time frame: 5 years from the enrollment of last patient
failure pattern
Time frame: 5 years from the enrollment of last patient
Number of Participants with Adverse Events
Time frame: up to 60 days after treatment
Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy
Time frame: 5 years
Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Time frame: 5 years from the enrollment of the last patient
Comparison of OS according to metabolic response after induction chemotherapy
Time frame: 5 years from the enrollment of the last patient
Quality of life
Time frame: 5 years from the enrollment of the last patient
Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Time frame: 5 years from the enrollment of the last patient
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Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Time frame: 5 years from the enrollment of the last patient
Comparison of PFS according to metabolic response after induction chemotherapy
Time frame: 5 years from the enrollment of the last patient
Comparison of TTF according to metabolic response after induction chemotherapy
Time frame: 5 years from the enrollment of the last patient
treatment-related mortality
Time frame: up to 60 days after completion of treatment