The purpose of this experiment is to study the alleviating effects and side effects of different laser irradiation doses on esophageal stricture of esophageal cancer in order to find the appropriate dose of light.
Background: Photodynamic therapy (PDT) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. This study aims to pursue the appropriate dose of light. Aim: To compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture. Methods: Fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.Single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Double irradiation group: 46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2. Primary endpoints: ORR rates at 1 and 3 months, the quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, China
1 month objective response rate
Grade 3-4 dysphagia accounted
Time frame: 1 month after photodynamic irradiation
3 month objective response rate
Grade 3-4 dysphagia accounted
Time frame: 3 month after photodynamic irradiation
3 month Quality of Life score
Time frame: 3 month after photodynamic irradiation
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