Electrochemotherapy of Head and Neck Cancer - Electrochemotherapy of Head and Neck Cancer

Rigshospitalet0 个研究点目标入组 29 人开始时间: 2013年8月22日最近更新: 2018年10月1日

适应症

试验速览

暂无简介。

•1. Histologically verified cancer of any type in the head and neck area.
•2. Progressive and/or metastatic disease
•3. Primary disease not eligible for surgery for patient’s general conditions or for the need of extensive surgery
•4. Patients must have been offered standard treatments
•5. Measurable lesions suitable for application of electric pulses
•6. Age> 18 yrs
•7. Performance status (Karnofsky = 70; WHO = 2)
•8. Life expectancy> 3 months
•9. Treatment free interval of at least 4 weeks after previously applied chemo- or radiotherapy to the target lesions
•10. Patients must be mentally capable of understanding the information given and sign 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 29
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 29

•1. Other symptomatic lesions not under control
•2. Lesions not suitable for electrochemotherapy (bony invasion, large vessels infiltration, etc.)
•3. Acute lung infection
•4. Symptoms of poor lung function necessitates DLCO and patient can not be treated if this is abnormal
•5. Severe coagulation disorders not correctable
•6. Previous allergic reactions to bleomycin
•7. If cumulative dose of 240000 IU BLM/m2 was previously exceeded
•8. Chronic renal dysfunction (creatinine > 150 µmol/L)
•9. Pregnancy or lactation

发起方