About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.
Disqualifiers
Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.
Active infection requiring systemic therapy.
Fever over 38 degrees Celsius
Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.
Trial design
Parallel
Treatments tested in this trial
Chemoradiotherapy
RadiationChemoradiotherapy
Treatment groups
Trial outcomes
Primary outcomes
Major 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.
Secondary outcomes
Overall survival
From date of randomization to date of death, approximately 5 years.
Progression-free survival
From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.
Complete response rate
CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.
Esophagectomy-free survival
From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.
Sponsors and contacts
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