Randomised Controlled Clinical Trial Investigating the Effect of Reduced Bleomycin in Electrochemotherapy Treatment on Patients with Cutaneous Malignancies (The Bless trial)

Region Sjaelland0 个研究点目标入组 55 人开始时间: 2024年4月8日最近更新: 2024年7月22日

试验速览

暂无简介。

•1.Trial subject > 18 years., Signed informed consent., Trial subject must be able to understand the participant information., Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology., Life expectancy > 3 months., Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study., Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed., Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed., A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance > 50 ml/min., Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization.

•Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment., Allergy or hypersensitivity to bleomycin., Acute lung infection., Severely impaired lung function or any lung condition the investigator deems severe., Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit., The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.

发起方

Region Sjaelland