Electrochemotherapy for the Treatment of Vulvar Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of adverse events 1 month after the treatment
研究概览
简要总结
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local recurrence of vulvar cancer confirmed by histology
- •The longest diameter of tumor 50 millimeters or less
- •Age more than 18 years
- •Life expectancy of more than 3 months
- •Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale
- •At least 2 weeks have passed since the last treatment
- •The patient must be able to understand the treatment process and possible side effects that may occur during the treatment
- •Signed informed consent form
- •The patient must be presented at a Multidisciplinary Tumor Board
排除标准
- •Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
- •Regional or distant metastases
- •Age less than 18 years
- •Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
- •Exposure to cumulative bleomycin doses greater than 400 mg
- •Impaired renal function (Creatinine > 150 µmol/L)
- •Patients who are unable to understand the treatment process or refuse to be involved in the treatment process
研究组 & 干预措施
Electrochemotherapy
干预措施: Electrochemotherapy with bleomycin or cisplatin (Drug)
结局指标
主要结局
Number of adverse events 1 month after the treatment
时间窗: 1 month
According to CTCAE v5.0
Number of adverse events 3 months after the treatment
时间窗: 3 months
According to CTCAE v5.0
Number of adverse events 6 months after the treatment
时间窗: 6 months
According to CTCAE v5.0
Number of adverse events 9 months after the treatment
时间窗: 9 months
According to CTCAE v5.0
Number of adverse events 12 months after the treatment
时间窗: 12 months
According to CTCAE v5.0
Number of adverse events 2 months after the treatment
时间窗: 2 months
According to CTCAE v5.0
Response of the tumor to electrochemotherapy according to RECIST criteria
时间窗: 12 months
According to RECIST criteria
次要结局
未报告次要终点