2022-500107-50-00招募中4 期
Cholangiocarcinoma treatment with radiofrequency ablation or photodynamic therapy
University Of Leipzig23 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2022年8月24日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 258
- 试验地点
- 23
- 主要终点
- The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model.
研究概览
简要总结
Does PDT or RFA lead to longer survival?
研究设计
- 分配方式
- Randomized
- 主要目的
- All Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Hilar cholangiocarcinoma (cytological or histological confirmation)
- •Surgery is not planned
- •Age 18 or older
- •Written informed consent
排除标准
- •Tumour not accessible endoscopically
- •Planned surgical procedure within the next 30 days
- •Concurrent eye disease that will require a slit lamp examination within the next 30 days
- •Prior radiotherapy within the last four weeks
- •Previous PDT or RFA
- •Planned liver transplantation
- •Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- •Leukopenia (< 2000/mm³)
- •Thrombocytopenia (< 100,000/mm³)
- •Severe, uncorrected coagulopathy (at the discretion of the physician)
- •Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
- •Porphyria (clinician’s assessment) or other light-exacerbated diseases
- •Severely impaired liver and or kidney function (at the discretion of the physician)
- •Bedridden for more than 50% of the time (similar to ECOG grade 3)
结局指标
主要结局
The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model.
The primary endpoint is overall survival, i.e. time from randomization to death from any cause or to the last known date on which the patient was alive. The comparison between arms will be based on the hazard ratio as estimated from a Cox regression model.
次要结局
- Overall survival (complementary perspectives)
- Days alive and out of hospital up to two years
- Quality of Life (QoL) at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value)
- Quality-adjusted life years (QALYs)
- Stent patency based on clinician’s assessment (e.g. cholangitis, cholestasis, ultrasound)
- Laboratory parameters
- Pruritus as a function of time up to two years will be considered
研究者
Prof. Albrecht Hoffmeister
Scientific
University Of Leipzig
研究点 (23)
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