To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery
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
Chang Gung Memorial Hospital
18 participants
Mar 30, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria4
- T4b tumor status (tracheal / bronchial mucosa, aortic involvement, or fistula formation).
- Stenosis of esophageal lumen that cannot be bypassed by the applicator.
- The primary tumor length exceeds 20cm.
- The patient is participating in other clinical trials.
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05145647