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Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma

Esophagus Cancer Clinical Trial

Official title:
A Phase III Randomized Controlled Study of the Effect of Different Light Doses on Adverse Outcomes of Swallowing in Esophageal Cancer

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05174117
Study type Interventional
Source The First Affiliated Hospital of Henan University of Science and Technology
Contact Shegan Gao, MD, PhD
Phone 18638859977
Email gsg112258@163.com
Status Not yet recruiting
Phase N/A
Start date January 1, 2022
Completion date June 30, 2023
View Details
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