A Phase III Randomized Controlled Study of the Effect of Different Light Doses on Adverse Outcomes of Swallowing in Esophageal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- 1 month objective response rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •esophagus cancer
- •18-80 years old
- •grade 3-4 dysphagia （Stoller classification）
- •Non-eradicative second-line treatment
排除标准
- •Ulcerative tumor
- •Esophageal stenosis caused by radiotherapy
- •Survival is less than 3 months
- •Patients known to be allergic to photosensitizers
研究组 & 干预措施
single irradiation group
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
干预措施: single irradiation (Combination Product)
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.
干预措施: Double irradiation (Combination Product)
结局指标
主要结局
1 month objective response rate
时间窗: 1 month after photodynamic irradiation
Grade 3-4 dysphagia accounted
3 month objective response rate
时间窗: 3 month after photodynamic irradiation
Grade 3-4 dysphagia accounted
次要结局
- 3 month Quality of Life score(3 month after photodynamic irradiation)