EUCTR2018-003531-30-IT进行中（未招募）1 期
Electrochemotherapy versus narrow excision margins for high-risk, primary cutaneous melanoma - WIDECT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Histologically confirmed diagnosis of cutaneous melanoma
- •Stage of disease: single, primary, localized cutaneous melanoma 2 mm or greater in thickness Breslow on the trunk or limbs (excluding soles of the feet)
- •Performance status (PS) according to The Eastern Cooperative Oncology Group (ECOG) = 2
- •Written informed consent
- •Use of an acceptable mean of contraception for men and women of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Diagnosis of mestastatic melanoma.
- •Serious coagulation abnormality, INR above 1.5
- •Absolute neutrophil count below 1,000/ml
- •Platelet count below 70,000/ml
- •Hemoglobin = 9 gr/dl
- •Known allergies to Bleomycin
- •Cumulative lifetime dose of Bleomycin exceeding 250 mg/m2
- •Peripheral neuropathy greater than grade 2
- •Chronic renal deficiency (creatinine>1.5 µg/L)
- •Active infection
- •Cardiac arrhythmias [e.g., significant ventricular arrhythmia such as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrioventricular block 2 and 3, sinoatrial block]
- •Pregnant or breastfeeding
- •Any other cancer from which the patients had been disease free for less than 5 years (except treated and cured basal–cell or squamous-cell skin cancer, superficial bladder cancer, or treated carcinoma in situ of the cervix, breast, or bladder)
- •Pulmonary infection
- •Severely impaired lung function
研究者
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