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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05174117
• Other study ID #: ECPDT-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2021
• Source: The First Affiliated Hospital of Henan University of Science and Technology
• Contact: Shegan Gao, MD, PhD
• Phone: 18638859977
• Email: gsg112258[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Combination Product:
• single irradiation
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
• Double 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (6)

Lee HH, Choi MG, Hasan T. Application of photodynamic therapy in gastrointestinal disorders: an outdated or re-emerging technique? Korean J Intern Med. 2017 Jan;32(1):1-10. doi: 10.3904/kjim.2016.200. Epub 2017 Jan 1. Review. — View Citation

Liu H, Liu Y, Wang L, Ruan X, Wang F, Xu D, Zhang J, Jia X, Liu D. Evaluation on Short-Term Therapeutic Effect of 2 Porphyrin Photosensitizer-Mediated Photodynamic Therapy for Esophageal Cancer. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819831989. doi: 10.1177/1533033819831989. — View Citation

National Health Commission Of The People's Republic Of China. Chinese guidelines for diagnosis and treatment of esophageal carcinoma 2018 (English version). Chin J Cancer Res. 2019 Apr;31(2):223-258. doi: 10.21147/j.issn.1000-9604.2019.02.01. — View Citation

Yano T, Minamide T, Takashima K, Nakajo K, Kadota T, Yoda Y. Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer. J Clin Med. 2021 Jun 24;10(13). pii: 2785. doi: 10.3390/jcm10132785. Review. — View Citation

Yoon HY, Cheon YK, Choi HJ, Shim CS. Role of photodynamic therapy in the palliation of obstructing esophageal cancer. Korean J Intern Med. 2012 Sep;27(3):278-84. Epub 2012 Sep 1. — View Citation

Zeng R, Liu C, Li L, Cai X, Chen R, Li Z. Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820930335. doi: 10.1177/1533033820930335. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 month objective response rate	Grade 3-4 dysphagia accounted	1 month after photodynamic irradiation
Primary	3 month objective response rate	Grade 3-4 dysphagia accounted	3 month after photodynamic irradiation
Secondary	3 month Quality of Life score		3 month after photodynamic irradiation