ISRCTN14633165已完成未知
Efficacy and safety of electrochemotherapy in basal cell carcinoma: A single-arm observational cohort study
Veneto Institute of Oncology IOv-IRCCS0 个研究点目标入组 84 人开始时间: 2017年3月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 84
研究概览
简要总结
2017 results in https://pubmed.ncbi.nlm.nih.gov/28569161/ (added 26/11/2020)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or older
- •2. Cutaneous / subcutaneous histologically confirmed skin metastases or primary or recurrent basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- •3. Measurable disease
- •4. Unresponsive or unsuitable for conventional treatments
- •5. In case of local BCC, the patients have to present with =2 tumors when located in the face or with =3 tumors when located in other anatomical regions
- •6. Patients with laBCC had at least one lesion >2 cm or any size plus ?2 risk features so that surgical resection was deemed inappropriate; moreover, laBCC have to be previously irradiated or, alternatively, radiation therapy have to be considered contraindicated or inappropriate (e.g. multifocal disease)
- •7. All subject have to be discussed in the frame of a multidisciplinary team
- •8. Tumor size smaller than 3 cm in thickness
- •9. Tumor not deeper than 3 cm
- •10. No concomitant treatments one month before and two months following ECT
- •11. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
- •12. Life expectancy of at least three months
- •13. Normal hematologic, hepatic and renal function
排除标准
- •1. Abnormal respiratory function
- •2. A cardiac pacemaker or arrhythmias
- •3. Previous maximal exposure to bleomycin
- •4. History of seizures
研究者
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