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

RecruitingPhase 3Ages 18 Years - 75 YearsAllShanghai Chest Hospital
NCT04135664 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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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What it tests

  • esophagectomy
  • chemoradiation
  • active surveillance
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Where

6 sites
The First Affiliated Hospital of Nanchang University
Nanchang, China
Changhai Hospital, The Second Military Medical University
Shanghai, China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, China
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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