Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Tumour response (size)
研究概览
简要总结
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.
详细描述
This will be a non-randomized phase II trial with the objective of evaluating the clinical response rate of calcium electroporation treatment of malignant tumours of the skin and assessing treatment impact on quality of life. This study will investigate the response rate of calcium electroporation treatment of skin metastases and malignant wounds in a real-world setting, in three different cancer centres in Northern Europe. The centres aim to treat a total of 30 patients with cancer in the skin of any histology. The patients will be treated once and followed with regular examinations for 12 months, starting from first treatment day. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.
The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. A subset of patients will undergo MR scans after treatment and another subset of patients will be interviewed regarding treatment impact on quality of life.
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
- •Trial subject ≥ 18 years.
- •Trial subject must be able to understand the participant information.
- •Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
- •The patient must have been offered other relevant standard treatment for their cancer disease.
- •The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
- •The patient can undergo radiation therapy, provided that the treatment field does not involve treated area.
- •Performance status ECOG/WHO ≤
- •At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
- •Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch).
- •Signed informed consent.
排除标准
- •Pregnancy or lactation
结局指标
主要结局
Tumour response (size)
时间窗: 2 months
Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
次要结局
- Systemic immunologic response evaluated by routine scans(12 months)
- Assessment of residual tumor from biopsies after 1 year(12 months)
- MRI scans to verify treatment and evaluate tumour changes after treatment(2 months)
- Evaluation of patient quality of life before and after treatment using EORTC Questionnaires.(13 months)
- Treatment response up to 12 months (size)(13 months)
- Individual response(12 months)
- Importance of irradiation(12 months)
- Current measurement(1 day)
- Response according to tumour histology(12 months)
- Remission(12 months)
- Evaluation of changes in quality of life through qualitative interview(2 months)