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Recruiting Phase 3 NCT04135664

Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

Trial Parameters

Condition Esophageal Cancer
Sponsor Shanghai Chest Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 176
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2019-09-01
Completion 2027-12-01
Interventions
esophagectomychemoradiationactive surveillance

Brief Summary

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

Eligibility Criteria

Inclusion Criteria: * Biopsy proven with esophageal squamous cell cancer. * Clinical N0 stage diagnosed by imaging examinations. * Pathological T1b stage confirmed by endoscopic submucosal dissection. * Age: 18-75. * Tumor located at the thorax. * Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Written informed consent. Exclusion Criteria: * Prior intervention treatment before endoscopic submucosal resection. * Inability to accept any treatment component. * Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease. * Distant metastasis. * The circumference of the lumen over 3/4 * Main tumor size \> 5cm assessed by endoscopy * Inability to understand the informed consent.

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