A randomized multicenter noninferiority trial comparing chemoradiotherapy versus esophagectomy after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma

Samsung Medical Center0 个研究点目标入组 240 人开始时间: 待定最近更新: 2019年6月17日

适应症

试验速览

暂无简介。

•1. Age = 19 years and < 80 years
•2. Histologically confirmed squamous cell carcinoma of the esophagus
•3. Participants underwent endoscopic submucosal dissection for clinical stage as cT1N0M0 (AJCC/UICC 7th Edition) esophageal cancer according to upper GI endoscopy or endoscopic ultrasound and chest computed tomography (CT) scans
•4. Pathologic examination after endoscopic submucosal dissection confirmed the presence of submucosal invasion (pathologic T1b) or lymphovascular invasion
•5. For participants with multiple lesions, all of them should be resected with endoscopic submucosal dissection and at least one lesion should have pathologic submucosal invasion (pT1b) or lymphovascular invasion
•6. articipants should agree to participate in the study and sign the informed consent form

•1. Cervical esophageal cancer (proximal to 20cm from incisor teeth)
•2. Regional lymph node metastasis (cN+) or distant metastasis (cM1) are suspected or confirmed on chest CT scans or positron emission tomography (PET)/CT scans
•3. Recurrent esophageal cancer
•4. Uncontrolled systemic disease which makes participants medically unfit for additional treatment (esophagectomy or concurrent chemoradiotherapy) such as congestive heart failure, interstitial lung disease, severe pulmonary emphysema or chronic renal failure
•5. Gastric conduit is not available for esophageal reconstruction (ex.: previous history of gastrectomy)
•6. Synchronous or metachronous multiple cancers (within the past 3 years) with the exclusion of skin cancer, well differentiated thyroid cancer, early gastric cancer achieving curative endoscopic resection, low grade prostate cancer (Gleason Score=6) )

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