A multicentre, prospective, randomised study of the value of a single dose of intravesical Mitomycin-C in preventing the development of bladder tumours following nephroureterectomy for transitional cell carcinoma (TCC) of the upper urinary tract

Sussex NHS Research Consortium (UK)0 个研究点目标入组 268 人开始时间: 2005年9月2日最近更新: 2018年11月12日

适应症

试验速览

•1. A new clinical diagnosis of a transitional cell tumour of the upper urinary tract above the intramural ureter
•2. A negative cystoscopy for TCC bladder within one month of the nephroureterectomy
•3. A nephroureterectomy that is planned to be performed in such a way that there is early distal ligation of the ureter prior to the mobilisation of the tumour. The intramural portion of the ureter may be resected prior to the open part of the operation, taken at the open operation with a cuff of bladder or everted at the end of the operation and resected endoscopically according to surgical preference.
•4. Have a life expectancy of at least one year
•5. Informed consent to participate (written and witnessed)

•1. The histology of the upper tract tumour does not confirm a transitional cell carcinoma
•2. Stage N1 or M1
•3. Had additional systemic chemotherapy or additional intravesical Mitomycin-C at follow up cystoscopies
•4. Existing or previous transitional cell carcinoma of bladder
•5. Children, pregnant women excluded
•6. Life expectancy less than one year
•7. Known sensitivity to Mitomycin-C

发起方

Sussex NHS Research Consortium (UK)