Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36343644
Enrollment
268
Registered
2005-09-02
Start date
2000-07-20
Completion date
Unknown
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper tract TCC bladder Cancer Malignant neoplasm of bladder

Interventions

Intravesical instillation of Mitomycin-C post operatively versus no Mitomycin-C

Sponsors

Sussex NHS Research Consortium (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Secondary

MeasureTime frame
To study the post surgical survival of these patients over five years.

Primary

MeasureTime frame
Incidence of tumour recurrence at 1 year post nephroureterectomy

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026