Adding Brachytherapy After Chemoradiotherapy for Esophageal Cancer

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

This study is testing if adding a new type of targeted radiation therapy after chemotherapy and radiation can help people with esophageal cancer who aren't having surgery control their tumors better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 20 Years to 85 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Taoyuan City)
• Trial ID: NCT05145647 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of adding intraluminal brachytherapy using an innovative applicator after definitive concurrent chemoradiotherapy (CCRT) in patients with resectable esophageal cancer who have opted out of surgery. The primary goal is to observe changes in local tumor control rates, while secondary goals include assessing treatment-related toxicity, progression-free survival, and overall survival. The new brachytherapy applicator aims to enhance therapeutic efficacy by minimizing dose inhomogeneity in the esophageal wall, potentially reducing the risk of severe side effects associated with traditional methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20-85 with clinical stage I-III thoracic esophageal cancer who have completed CCRT and have resectable tumors but declined surgery.

Not a fit: Patients with advanced T4b tumors, significant esophageal stenosis, or those participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control and reduce complications for patients with esophageal cancer.

How similar studies have performed: While brachytherapy has been used in esophageal cancer treatment, the specific application of the innovative Braxx applicator represents a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Taoyuan City

• Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chen-Kan Tseng, MD — Chang Gung Memorial Hospital
• Study coordinator: Chen-Kan Tseng, MD

Conditions Esophageal Cancer