Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Safety and response
研究概览
简要总结
By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. The investigators wish compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.
详细描述
About 5 % of all cancer patients experience cutaneous metastases. Ulcerating metastases can be of great psychological distress for the patients and may also be painful. Radiation therapy is standard treatment for ulcerating metastases, but there are no reports of response rate.
With this study we wish to compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.
Patient recruitment: 98 patients are to be recruited, the patients will be randomized between electrochemothreapy or radiotherapy. 49 patients will be treated in each arm.
Treatment: Patients will be treated in local or general anesthesia (inhaling max. 30 % oxygen) Bleomycin will be given either intratumoral or intravenous. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5000 Hz or 1 Hz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.
The patients will be seen at 8, 30, 60, 90 and 180 days post treatment. Chest X ray will be taken before and after treatment for the patients receiving electrochemotherapy.
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
- 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
- •Histological proven cancer, any histology.
- •Progressive and/or metastatic disease.
- •One or more ulcerating cutaneous metastases.
- •Patient in need of palliation of the ulcerating metastases.
- •Lesion to be treated between 1 cm - 5 cm in diameter.
- •Lesions to be treated must be either stationary or progressing during any concomitant chemotherapy.
- •WHO performance ≤
- •Life expectancy of at least 3 months.
- •Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed.
- •Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
- •Written informed consent must be obtained according to the local Ethics committee requirements.
排除标准
- •Previous electrochemotherapy or radiotherapy in the area to be treated
- •Acute lung infection
- •Previous bleomycin treatment exceeding 200.000 Units/m
- •Known hypersensitivity to any of the components of the treatment.
- •Known hypersensitivity to any of the components used in the planned anaesthesia.
- •Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood.
- •Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.
- •Creatinine measurements over 150 micromolar will require Crohm-EDTA clearance. Crohm-EDTA below 48 ml/minute
- •Abnormal DLCO. If clinical history of or suspected reduced lung capacity, DLCO must be performed.
研究组 & 干预措施
Electrochemotherapy
干预措施: Electrochemotherapy (Drug)
Electrochemotherapy
干预措施: Bleomycin (Drug)
radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Safety and response
时间窗: 30 days
次要结局
- patient satisfaction(180)
- Economics(180 days)