Spots Global Cancer Trial Database for Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma
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Trial Identification
Brief Title: Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma
Official Title: A Phase III Randomized Controlled Study of the Effect of Different Light Doses on Adverse Outcomes of Swallowing in Esophageal Cancer
Study ID: NCT05174117
Conditions
Study Description
Brief 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.
Detailed 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路cm-2, irradiation time: 900s, volume density: 180 J路cm-2;Double irradiation group: 46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW路cm-2, irradiation time: 900s, volume density: 180 J路cm-2;Power density: 200mW路cm-2, irradiation time: 300s, volume density: 60 J路cm-2. Primary endpoints: ORR rates at 1 and 3 months, the quality of life
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, China
Contact Details
Name: Shegan Gao, MD, PhD
Affiliation: The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
Role: STUDY_CHAIR
Name: Tanyou Shan, MD, PhD
Affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Role: STUDY_DIRECTOR
Name: Caihong Dong, MD, PhD
Affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Wanying Li, MD
Affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Jiachun Sun, MD, PhD
Affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Mengxi Zhang, MD, PhD
Affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaozhi Yuan, MD, PhD
Affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
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