Evaluating the addition of brachytherapy for esophageal cancer treatment
A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
This study is testing whether adding a special type of radiation treatment after chemotherapy and radiation can help people with esophageal cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06365866 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of adding intraluminal brachytherapy using the BRAXX applicator after definitive chemoradiotherapy (CCRT) in patients with thoracic esophageal cancer. Patients will receive high-dose-rate brachytherapy within 12 weeks following external beam radiotherapy, with careful monitoring of tumor response through imaging and endoscopic evaluations. The study will also track any adverse effects and adjust treatment as necessary based on patient tolerability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-85 with clinical stage I-IV thoracic esophageal cancer who have completed CCRT.
Not a fit: Patients with double cancers, significant esophageal stenosis, or those scheduled for surgical treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with thoracic esophageal cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing treatment efficacy for esophageal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Pin-I Huang, Ph.D — Taipei Veterans General Hospital, Taiwan
- Study coordinator: Pin-I Huang, Ph.D
- Email: pihuang@vghtpe.gov.tw
- Phone: +886-2-2875-7270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.