Clinical trial · Interventional
To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery
To Observe the Local Tumor Recurrence Rate of Adding Intraluminal Brachytherapy With Balloon Applicator After Standard Definitive Concurrent Chemoradiotherapy (CCRT) on Local-regional Thoracic Esophageal Cancer Patients Who Refused Surgery
- 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)
Clinical experience of adding intraluminal brachytherapy with traditional applicator after definitive concurrent chemoradiotherapy (CCRT) for local-regional thoracic esophageal cancer is limited due to high complication risk and non-superiority in survival. The innovative applicator can maximize the therapeutic efficacy by reducing dose inhomogeneity in the esophageal wall, which will translate into less over-dosing and less risk of the side effects of fistula or stenosis. The primary goal of this study by using new applicator is to observe the change in local tumor control rate, while secondary goals are treatment related toxicity, progression-free survival, and overall survival.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Add-on Brachytherapy | Radiation | — | UNRESOLVED |
| "BRAXX" Esophageal Brachytherapy Applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Add-on Brachytherapy
- description
- The evaluation for feasibility of surgery takes place 5-6 weeks after CCRT. Any subject whose tumor status is resectable at evaluation but declines surgical proposal will be eligible to be enrolled in the following study phase.
- interventionNames
- Radiation: Add-on Brachytherapy
- Device: "BRAXX" Esophageal Brachytherapy Applicator
Primary outcomes (1)
- measure
- To estimate the local control rate at primary tumor site
- timeFrame
- 12 months after completion of treatment
- description
- Enrolled subject will be followed every 3 months after treatment, EGD-endoscope (± biopsy) will be arranged at Month 3, 6, 9, 12 and CT scans on Month 6, 12, to evaluate the tumor status.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 20-85 years, with ECOG performance 0-2 2. Thoracic esophageal cancer with clinical stage I-III and biopsy proof; patient with cervical esophageal cancer or stage IV thoracic esophageal cancer could be recruited in this trial according to Investigator's assessment. 3. Complete first course CCRT with minimum doses of 40 Gy to tumor and nodal area via external beam radiotherapy (EBRT). 4. Patient whose tumor is resectable but declined to receive surgery after first course CCRT. Exclusion Criteria: 1. T4b tumor status (tracheal / bronchial mucosa, aortic involvement, or fistula formation). 2. Stenosis of esophageal lumen that cannot be bypassed by the applicator. 3. The primary tumor length exceeds 20cm. 4. The patient is participating in other clinical trials.
References
Publications (0)
Data not yet available