Clinical trial · Observational
Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection
Selective Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection- a Multicenter, Retrospective Study
- 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)
Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high. Although, adjuavnt chemoradiotherapy is recommended, limied studies prove the superiority of additional adjuvant radiotherapy over ESD alone. This study aimed to further verify the efficacy of adjuvant radiotherapy in early-stage esophageal cancer after ESD.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- ESD group
- description
- ESD was performed by a highly experienced endoscopist who underwent systemic training. First, the endoscopist carried out chromoendoscopy by spraying 1.25% Lugol's iodine solution to identify the lesion and made dots with a dual-knife outside the margin of the lesion. Next, a forward-viewing endoscope was introduced with a transparent cap attachment on its tip. A saline solution with methylene blue and epinephrine was injected into the submucosa with an injection needle to create a liquid cushion separating the lesion and the muscle layer. Then, a mucosal incision at the periphery of the marking dots was performed with a dual-knife. After that, the submucosal connective tissue beneath the lesion was dissected using the same dual-knife, and the lesion was totally removed through dissection.
- label
- ESD+adjuvant radiotherapy group
- description
- The process of ESD was the same as that of ESD group. A total dose of 41.4-60.0 Gy in common fractionation based on three-dimensional conformal radiotherapy or intensity modulated radiotherapy technology was prescribed.
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- 3-year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: (1) ECOG score \< 2; (2) Pathologically confirmed squamous or adenosquamous cell cancer; (3) Clinical stage cTis-1bN0M0; (4) Multiple primary T1 lesions were allowed; (5) No lymph nodes and distant metastases confirmed by chest CT, neck CT or neck ultrasound, and abdominal CT or abdominal ultrasound; (6) Underwent ESD between January 2010 and December 2019; (7) pT1b disease confirmed by endoscopically resected specimen; (8) Underwent adjuvant radiotherapy (with or without chemotherapy) or surveillance after ESD. Exclusion Criteria: (1) Diagnosed with other locally-advanced or advanced malignancies within 3 years before ESD; (2) Underwent radical surgery after ESD; (3) Upfront radiotherapy, chemotherapy or chemoradiotherapy before ESD; (4) Lost to follow-up or insufficient clinical information.
References
Publications (0)
Data not yet available