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

Status: Recruiting
Location: See location...
Intervention Type: Device, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: f
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• Age of 20-85 years, with ECOG performance 0-2

• 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.

• Complete first course CCRT with minimum doses of 40 Gy to tumor and nodal area via external beam radiotherapy (EBRT).

• Patient whose tumor is resectable but declined to receive surgery after first course CCRT.

Locations
Other Locations
Taiwan
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Contact Information
Primary
Chen-Kan Tseng, MD
kantseng@adm.cgmh.org.tw
+886-3-3281200
Time Frame
Start Date: 2022-03-30
Estimated Completion Date: 2025-06-18
Participants
Target number of participants: 18
Treatments
Experimental: Add-on Brachytherapy
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.
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov