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To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery

NCT05145647 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

RADIATION

Add-on Brachytherapy

Brachytherapy protocol starts within 2 weeks after consolidative EBRT, subjects who are enrolled will receive brachytherapy with specified balloon applicator. High-dose-rate (HDR) brachytherapy system will be used in the treatment, 5-Gy per fraction is delivered to the pre-treatment esophageal length of primary tumor(s), second treatment if applicable will be finished within 2 weeks after the first one, a total of 5-10Gy in 1-2 fractions will be delivered.

DEVICE

"BRAXX" Esophageal Brachytherapy Applicator

The device is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chen-Kan Tseng, MD · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2026-10-18
Completion
2026-10-18

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145647 on ClinicalTrials.gov