Clinical trial · Interventional
Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer.
A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
NCT06365866CI-TRIAL-00076038unknownN/AClinicalTrials.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 purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Diseases | — | UNRESOLVED | — |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Diseases | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Diseases | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Add-on of intraluminal brachytherapy | Radiation | — | UNRESOLVED |
| "BRAXX" Esophageal Brachytherapy Applicator. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Add-on of intraluminal brachytherapy with "BRAXX" Esophageal Brachytherapy Applicator.
- description
- Brachytherapy protocol starts 3 weeks after EBRT (This is "week 1"). After transnasal insertion of the applicator into the esophagus, CT simulation scan(s) with a dummy source in place will be done for further planning procedures, including adjustment of the applicator and 3D treatment planning.
- interventionNames
- Device: "BRAXX" Esophageal Brachytherapy Applicator.
- Radiation: Add-on of intraluminal brachytherapy
Primary outcomes (1)
- measure
- To estimate the local control rate at primary tumor site.
- timeFrame
- 12 months after completion of treatment
- description
- Subjects will be followed every 3 months after treatment, EGD-endoscopy (± biopsy) and PET/ CT scans will be arranged in Months 3, 6, 9, and 12 to evaluate the tumor status.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 20-85 years, with ECOG performance 0-2. * Thoracic esophageal cancer with clinical stage I-IV and biopsy proof; patient with stage I-IV cervical esophageal cancer could be recruited in this trial according to Investigator's assessment. * Complete CCRT with total doses of 45-55Gy to GTV via external beam radiotherapy (EBRT). Exclusion Criteria: * According to Investigator's assessment, patients with double cancer or recurrence could be recruited in this trial if they continue to receive systemic therapy. * Patient with double cancer, esophageal cancer or recurrence who is scheduled for surgery treatment. * Involvement of tracheal mucosa or bronchial mucosa. * Stenosis of esophageal lumen that cannot be bypassed by the applicator after EBRT. * The distribution of the lesions of interest exceeds 10cm range. * The patient is participating in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.