TREATMENT OF Ta BLADDER CANCER WITH HIGH RISK OF RECURRENCE – FLUORESCENCE CYSTOSCOPY WITH OPTIMIZED ADJUVANT MITOMYCIN-C - FLUORESCENCE CYSTOSCOPY AND OPTIMIZED MMC IN RECURRENT BLADDER CANCER (FINNBLADDER 9)

FinnBladder0 个研究点开始时间: 2012年8月23日最近更新: 2012年9月18日

适应症

试验速览

暂无简介。

•1) Primary papillary bladder cancer at high risk for further recurrence
•- Number of primary tumors =2, OR
•- Size of solitary primary tumor = 3 cm, OR
•-Recurrent papillary tumors
•2) Histologically proven Ta bladder cancer
•3) Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer
•4) Written informed consent is required from every eligible patient
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1) Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
•2) CIS (carcinoma in situ)
•3) Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
•4) Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
•5) Suspicion or previous history of the patient not tolerating intravesical instillations
•6) Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)
•7) Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician)
•8) Pregnancy or lactating patient
•9) Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission =5 years)
•10) Age < 18 years
•11) Expected survival time less than one year
•12) Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)

发起方

FinnBladder