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.
研究概览
详细说明
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
研究类型
介入性
注册 (预期的)
57
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shegan Gao, MD, PhD
- 电话号码：18638859977
- 邮箱：gsg112258@163.com
研究联系人备份
- 姓名：Tanyou Shan, MD, PhD
- 电话号码：18537976669
- 邮箱：shantanyoudoctor@163.com
学习地点
-
-
Henan
-
Luoyang、Henan、中国、471003
- The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：single irradiation group
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
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46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
|
|
有源比较器：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1 month objective response rate
大体时间：1 month after photodynamic irradiation
|
Grade 3-4 dysphagia accounted
|
1 month after photodynamic irradiation
|
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3 month objective response rate
大体时间：3 month after photodynamic irradiation
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Grade 3-4 dysphagia accounted
|
3 month after photodynamic irradiation
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
3 month Quality of Life score
大体时间：3 month after photodynamic irradiation
|
3 month after photodynamic irradiation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Shegan Gao, MD, PhD、The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
- 研究主任：Tanyou Shan, MD, PhD、The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- 首席研究员：Caihong Dong, MD, PhD、The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- 首席研究员：Wanying Li, MD、The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- 首席研究员：Jiachun Sun, MD, PhD、The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- 首席研究员：Mengxi Zhang, MD, PhD、The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- 首席研究员：Xiaozhi Yuan, MD, PhD、The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年1月1日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2023年6月30日
研究注册日期
首次提交
2021年12月21日
首先提交符合 QC 标准的
2021年12月29日
首次发布 (实际的)
2021年12月30日
研究记录更新
最后更新发布 (实际的)
2021年12月30日
上次提交的符合 QC 标准的更新
2021年12月29日
最后验证
2021年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.