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

Henan University of Science and Technology

Status: Unknown

Conditions: Esophagus Cancer

Treatments: Combination Product: Double irradiation; Combination Product: single irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05174117

ECPDT-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• esophagus cancer
• 18-80 years old
• grade 3-4 dysphagia （Stoller classification）
• Non-eradicative second-line treatment

Exclusion criteria

• Ulcerative tumor
• Esophageal stenosis caused by radiotherapy
• Survival is less than 3 months
• Patients known to be allergic to photosensitizers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

single irradiation group

Experimental group

Description:

46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2

Treatment:

Combination Product: single irradiation

Double irradiation group

Active Comparator group

Description:

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.

Treatment:

Combination Product: Double irradiation