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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophagus Cancer
• Intervention / Treatment: Combination product: single irradiation; Combination product: Double irradiation

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

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shegan Gao, MD, PhD; Phone Number: 18638859977; Email: gsg112258@163.com
• Study Contact Backup: Name: Tanyou Shan, MD, PhD; Phone Number: 18537976669; Email: shantanyoudoctor@163.com

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single irradiation group; 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2	Combination product: single irradiation; 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
Active Comparator: 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.	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
3 month Quality of Life score	3 month after photodynamic irradiation

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
• Investigators: Study Chair: Shegan Gao, MD, PhD, The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology; Study Director: Tanyou Shan, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology; Principal Investigator: Caihong Dong, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology; Principal Investigator: Wanying Li, MD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology; Principal Investigator: Jiachun Sun, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology; Principal Investigator: Mengxi Zhang, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology; Principal Investigator: Xiaozhi Yuan, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.3904/kjim.2012.27.3.278. Epub 2012 Sep 1.
• 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.
• 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.
• 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):2785. doi: 10.3390/jcm10132785.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Esophagus Cancer; Photodynamics Therapy; Laser dose
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ECPDT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No