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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05174117

Enrollment

Registered

2021-12-30

Start date

2022-01-01

Completion date

2023-06-30

Last updated

2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer

Keywords

Esophagus Cancer, Photodynamics Therapy, Laser dose

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·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

Interventions

COMBINATION_PRODUCTsingle irradiation

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

COMBINATION_PRODUCTDouble irradiation

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
1 month objective response rate	1 month after photodynamic irradiation	Grade 3-4 dysphagia accounted
3 month objective response rate	3 month after photodynamic irradiation	Grade 3-4 dysphagia accounted

Secondary

Measure	Time frame
3 month Quality of Life score	3 month after photodynamic irradiation

Countries

China

Contacts

Primary ContactShegan Gao, MD, PhD

gsg112258@163.com18638859977

Backup ContactTanyou Shan, MD, PhD

shantanyoudoctor@163.com18537976669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026