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

Primary Purpose

Esophagus Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
single irradiation
Double irradiation
Sponsored by
The First Affiliated Hospital of Henan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer focused on measuring Esophagus Cancer, Photodynamics Therapy, Laser dose

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

single irradiation group

Double irradiation group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

1 month objective response rate
Grade 3-4 dysphagia accounted
3 month objective response rate
Grade 3-4 dysphagia accounted

Secondary Outcome Measures

3 month Quality of Life score

Full Information

First Posted
December 21, 2021
Last Updated
December 29, 2021
Sponsor
The First Affiliated Hospital of Henan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05174117
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 Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Henan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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·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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer
Keywords
Esophagus Cancer, Photodynamics Therapy, Laser dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single irradiation group
Arm Type
Experimental
Arm Description
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
Arm Title
Double irradiation group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
single irradiation
Intervention Description
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
Intervention Type
Combination Product
Intervention Name(s)
Double irradiation
Intervention 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.
Primary Outcome Measure Information:
Title
1 month objective response rate
Description
Grade 3-4 dysphagia accounted
Time Frame
1 month after photodynamic irradiation
Title
3 month objective response rate
Description
Grade 3-4 dysphagia accounted
Time Frame
3 month after photodynamic irradiation
Secondary Outcome Measure Information:
Title
3 month Quality of Life score
Time Frame
3 month after photodynamic irradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shegan Gao, MD, PhD
Phone
18638859977
Email
gsg112258@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tanyou Shan, MD, PhD
Phone
18537976669
Email
shantanyoudoctor@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shegan Gao, MD, PhD
Organizational Affiliation
The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tanyou Shan, MD, PhD
Organizational Affiliation
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caihong Dong, MD, PhD
Organizational Affiliation
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wanying Li, MD
Organizational Affiliation
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiachun Sun, MD, PhD
Organizational Affiliation
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mengxi Zhang, MD, PhD
Organizational Affiliation
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaozhi Yuan, MD, PhD
Organizational Affiliation
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32578508
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.
Results Reference
background
PubMed Identifier
23019392
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. doi: 10.3904/kjim.2012.27.3.278. Epub 2012 Sep 1.
Results Reference
background
PubMed Identifier
30885065
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.
Results Reference
background
PubMed Identifier
28049283
Citation
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.
Results Reference
background
PubMed Identifier
34202917
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):2785. doi: 10.3390/jcm10132785.
Results Reference
result
PubMed Identifier
31156297
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. No abstract available.
Results Reference
result

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

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