Clinical trial NCT05174117: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Cancer
Keywords: Esophagus Cancer
Photodynamics Therapy
Laser dose
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 1 month objective response rate
timeFrame: 1 month after photodynamic irradiation
measure: 3 month objective response rate
timeFrame: 3 month after photodynamic irradiation
Secondary outcomes:
measure: 3 month Quality of Life score
timeFrame: 3 month after photodynamic irradiation
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
name: Shegan Gao, MD, PhD
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
name: Tanyou Shan, MD, PhD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
name: Caihong Dong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
name: Wanying Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
name: Jiachun Sun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
name: Mengxi Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
name: Xiaozhi Yuan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.