NCT03142061已完成不适用
Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Symptom control
研究概览
简要总结
Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma
详细描述
Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age ≥ 55 years (postmenopausal)
- •histologically proved cutan accessible vulva carcinoma
- •a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
- •applied electrochemotherapy with electroporation
排除标准
- •Non compliant patients
- •Patients with symptomatic or rapidly progredient metastasis outside of the vulva
结局指标
主要结局
Symptom control
时间窗: Baseline
exulceration, secretion
local tumor control
时间窗: Baseline
according to RECIST criteria
次要结局
- Pain(Baseline, 3, 6 months)
- Life quality(Baseline, 3, 6 months)
研究者
研究点 (2)
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