EUCTR2012-001248-23-DK进行中（未招募）1 期
Treatment of Inoperable Colorectal Cancer withElectrochemotherapy through an Endoscopic System - Colorectal cancer endoscopic electroporation (CCEE)
All Ireland Cooperative Oncology Research Group0 个研究点目标入组 30 人开始时间: 2014年5月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •1. Histologically verified colorectal tumour.
- •2. Case reviewed by a multidisciplinary team (MDT) (surgery, radiology, oncology, gastroenterology) and there are no curable options with the standard of care. The MDT considers all available treatment options and enrolment to this study is agreed as being appropriate;
- •Or the case is curable but patient refuses to undergo the standard of care. The MDT considers all possible alternatives, which are also discussed with the patient, and the MDT considers enrolment to this study as being the most appropriate option;
- •Or patients with advanced local disease with impending obstruction on endoscopic evaluation who are otherwise not suitable for surgical intervention or stenting, the MDT would also consider these patients for enrolment into this study.
- •3. Men or women aged at least 18 years.
- •?4. Performance status (Karnofsky > 60% or ECOG/WHO < 2).
- •5. Treatment free interval of at least 2 weeks after previously applied therapy.
- •6. Patients must be mentally capable of understanding the information given.
- •7. Patients must give written informed consent.
- •8. a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
- •- has had a hysterectomy
- •- has had a bilateral oophorectomy (ovariectomy) - has had a bilateral tubal ligation
- •- Is post-menopausal:
- •Performance status (Karnofsky >60 OR WHO < 2).
- •Treatment free interval of at least 2 weeks after previously applied therapy.
- •Patients must be mentally capable of understanding the information given.
- •Patients must give written informed consent.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Coagulation disorder
- •2. Patients with pre-existing renal dysfunction are excluded.
- •[Note: Creatinine clearance will be measured for all patients. For Bleomycin treatment: creatinine clearance must be greater than 40ml/min.]
- •3. Patients with a clinically manifested arrhythmia or with a pacemaker
- •4. Patients with epilepsy.
- •5. Pregnancy or lactation/breastfeeding.
- •6. Patient known to be Hepatitis B/C or HIV positive.
- •7. Concurrent treatment with an investigational medicinal product or participation in another clinical study.
- •8. Patients who have undergone a regime of Bevacizumab in the previous 4 weeks.
- •9. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
- •10. Highly inflamed colon tissue which is ulcerated and bleeding.
- •11. patients with colorectal stent
研究者
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