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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single irradiation group | Experimental | 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2 |
|
| Double irradiation group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single irradiation | Combination Product | 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3 month Quality of Life score | 3 month after photodynamic irradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shegan Gao, MD, PhD | Contact | 18638859977 | gsg112258@163.com | |
| Tanyou Shan, MD, PhD | Contact | 18537976669 | shantanyoudoctor@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shegan Gao, MD, PhD | The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology | Study Chair |
| Tanyou Shan, MD, PhD | The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology | Luoyang | Henan | 471003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32578508 | Background | 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. | |
| 23019392 | Background | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Double irradiation | Combination Product | 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. |
|
| 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 | Principal Investigator |
| 30885065 | Background | 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. |
| 28049283 | Background | 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. |
| 34202917 | Result | 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. |
| 31156297 | Result | 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. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |