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临床试验/NCT06709937
NCT06709937已完成不适用

Prospective Multicenter Registry of Patients With Skin Metastases From Breast Cancer Treated With Electrochemotherapy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
The rate of local response in the entire study population and in the subgroups

研究概览

简要总结

Electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma.

详细描述

Electrochemotherapy

Recently, electrochemotherapy (ECT) has been proposed as a new therapeutic option for palliating cutaneous metastases from breast carcinoma. Over the last decade, ECT has represented an innovative and effective local/regional therapy in the field of dermato-oncology. In brief, it consists of combining chemotherapy with the local application (at the tumor site) of electric pulses. Through the application of short and intense electric pulses, a physical phenomenon (reversible electroporation) occurs, consisting of the temporary opening of pores through the cell membrane, increasing its permeability. This mechanism allows for the diffusion of poorly permeable drugs into the cytoplasm. Once the transmembrane pores close, after a few milliseconds, the final effect is the concentration of the chemotherapeutic drug inside the cell and an increase in its cytotoxic effect. The enhancement of cytotoxic action ranges from 80 (in the case of cisplatin) to 8000 times (in the case of bleomycin).

Clinical experience with electrochemotherapy

The initial clinical experiences in treating patients with cutaneous metastases using ECT demonstrated very promising results in tumors of various histotypes. After the standardization of the method, studies published over the last decade provide extensive evidence that ECT has high antitumor activity. The most extensive experience has been primarily gathered in patients with superficial metastases from melanoma and breast carcinoma and has also been the subject of a meta-analysis comparing different "skin-directed" therapies.

In current clinical practice, ECT is employed as a complementary or alternative treatment in the management of tumors and cutaneous metastases that are not surgically resectable or not amenable to treatment with radiotherapy or systemic oncologic therapies. Thanks to its relative ease of application and low toxicity profile, ECT represents an effective tool for palliating symptomatic superficial metastases (bleeding, ulcerated, painful), ensuring preservation of the patient's quality of life regarding aspects related to the presence of the disease at the cutaneous level.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with cutaneous metastases from breast carcinoma not surgically resectable;
  • No indications for radiotherapy treatment;
  • Patients not eligible or not fully responsive to systemic oncologic treatments;
  • Maximum depth of the lesion from the skin surface: 3 cm;
  • Patient's life expectancy exceeding 4 months;
  • Normal hematologic, hepatic, and renal function;
  • Performance status ≤2 according to the ECOG scale.

排除标准

  • History of allergic reactions to bleomycin or cisplatin;
  • Exceeding the maximum cumulative dose of bleomycin (250,000 IU/m2);
  • Peripheral neuropathy (in case of cisplatin use);
  • Severe hepatic or renal insufficiency;
  • History of epilepsy;
  • Presence of a pacemaker;
  • Severe cardiac arrhythmias (In patients with a history of cardiac arrhythmia, a cardiological evaluation will be performed, and treatment will be applied in the presence of an anesthesiologist. The presence of any type of pacemaker precludes treatment on the thoracic wall);
  • Pregnancy or breastfeeding;
  • Unavailability for follow-up visits;
  • Altered respiratory function or presence of pulmonary fibrosis.

结局指标

主要结局

The rate of local response in the entire study population and in the subgroups

时间窗: 1-3-6 months

Confirmation with a large case series of the results obtained in the multicenter study by the GISEL group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Corrado Giacomo

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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