EUCTR2016-000135-40-DK进行中（未招募）1 期
Endoscopic assisted electrochemotherapy in addition to neoadjuvant treatment of locally advanced rectal cancer: a randomized clinical phase II trial. - Rectal cancer endoscopic electroporation
Zealand University Hospital, Department of Surgery0 个研究点目标入组 40 人开始时间: 2016年4月5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
- 40
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.Patient must be mentally capable of understanding the information given.
- •2.Patients must give written informed consent.
- •3.Histologically verified rectal tumor.
- •4.Men or women aged at least 18 years.
- •5.Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with neoadjuvant therapy followed by surgical excision (UICC stadium II-III).
- •6.ASA class I-III (Classification of the American Society of Anesthesiology)
- •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 30
排除标准
- •1.Coagulation disorder.
- •2.Patients with ICD or pacemaker units.
- •3.Patients with epilepsy.
- •4.Pregnancy or lactation/breastfeeding.
- •5.Patients with known Hepatitis B/C or HIV infection.
- •6.Patients who have undergone treatment with bevacizumab within 4 weeks prior to enrolment in this trial.
- •7.Patients with concomitant use of phenytoin.
- •8.Patients with concomitant use of clozapine.
- •9.Concurrent treatment with an investigational medicinal product.
- •10.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 recruitments.
- •11.Patients with contraindications for PET/MRI scan:
- •Claustrophobia.
- •Implanted pacemaker.
- •Heart-valve prosthesis.
- •Cochlea / stapes prosthesis.
- •Insulin pumps that cannot be removed.
- •Neuro-stimulators.
- •Metal clips after operations.
- •Other metal devices and foreign bodies.
- •Metal shrapnel(s).
- •Inserted and fixed catheters i.e. Swan-Ganz catheters.
- •Shunts and prosthesis.
- •12.Advanced tumor stage, UICC stage IV.
- •13.Patients with Contraindications for bleomycin:
- •Acute pulmonary infection.
- •Medical history of severe pulmonary disease.
- •Previous allergic reactions to bleomycin.
- •Previous cumulative dose of bleomycin exceeding 250mg/m2.
- •Pre-existing renal dysfunction. Bleomycin treatment: Creatinine clearance must be greater than 40 ml/min.
- •Platelet count =50 mia/l.
- •Prothrombin time = 40 sec.
- •14.Patients registered in the Danish Vævsanvendelsesregister”
研究者
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