Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial
Shanghai Chest Hospital
176 participants
Sep 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria7
- 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.
Interventions
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
concurrent chemotherapy and radiotherapy
No further adjuvant therapy
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT04135664