To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery
NCT05145647
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 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.
Conditions2
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NCT05145647