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Clinical Trials/ISRCTN36343644
ISRCTN36343644
Completed
未知

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 sites268 target enrollmentSeptember 2, 2005
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Conditionspper tract TCC bladderCancerMalignant neoplasm of bladder

Overview

Phase
未知
Intervention
Not specified
Conditions
pper tract TCC bladder
Sponsor
Sussex NHS Research Consortium (UK)
Enrollment
268
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21684068

Registry
who.int
Start Date
September 2, 2005
End Date
December 1, 2007
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sussex NHS Research Consortium (UK)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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