Clinical trial · Interventional
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
NCT04135664CI-TRIAL-00041246recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| active surveillance | Other | — | UNRESOLVED |
| chemoradiation | Combination Product | — | UNRESOLVED |
| esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Patients undergoing adjuvant esophagectomy
- description
- Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant esophagectomy.
- interventionNames
- Procedure: esophagectomy
- type
- EXPERIMENTAL
- label
- Patients undergoing adjuvant chemoradiation
- description
- Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant chemoradiation.
- interventionNames
- Combination Product: chemoradiation
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYang Y, Su Y, Zhang X, Liu J, Zhang H, Li B, Hua R, Tan L, Chen H, Li Z. Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial). Trials. 2020 Jul 1;21(1):603. doi: 10.1186/s13063-020-04461-5. PMID 32611448