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
- Conditions
- pper tract TCC bladderCancerMalignant neoplasm of bladder
- Registration Number
- ISRCTN36343644
- Lead Sponsor
- Sussex NHS Research Consortium (UK)
- Brief Summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21684068
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 268
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of tumour recurrence at 1 year post nephroureterectomy
- Secondary Outcome Measures
Name Time Method To study the post surgical survival of these patients over five years.