Status:
COMPLETED
Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Superficial Bladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Early single instillation of chemotherapy after TUR is recommended in the European Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients with multiple tumors, somet...
Eligibility Criteria
Inclusion
- All patients with primary histologically proven stage pTa-pT1 transitional-cell carcinoma of the bladder
Exclusion
- Previous treatments with bacillus Calmette-Guerin, mitomycin-C, or with any other intravesical cytostatic agent
- Concomitant urothelial tumours of the upper urinary tract
- Previous or concomitant muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
- Bladder capacity less than 200 ml
- Untreated urinary-tract infection
- Disease of upper urinary tract
- Previous radiotherapy to the pelvis
- Other concurrent chemotherapy
- Treatment with radiotherapy-response or biological-response modifiers
- Other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma)
- Pregnancy or nursing
- And psychological, familial or sociological factors that would preclude study participation
Key Trial Info
Start Date :
January 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT01149174
Start Date
January 1 1994
End Date
June 1 2009
Last Update
October 4 2011
Active Locations (1)
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1
Dept. of Surgery, Tor Vergata University
Rome, Italy, 00133