Trial | NCT01149174  Report issue

Title

Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer
Single Preoperative Intravesical Instillation of Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer: a Prospective Randomized Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mitomycin ...

  • Study Participants

    352
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, sometimes is not tolerated and it can results in severe complications. In both laboratory and clinical studies, intravesical electromotive drug administration (EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical efficacy in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the effects of one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate post-TUR intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients with NMIBC.

All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo transurethral resection alone (TUR/alone); TUR plus single immediate postoperative instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20 mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate and disease-free interval. All clinical analyses will be performed on an intent to treat basis.
Study Started
Jan 31
1994
Primary Completion
Dec 31
2003
Study Completion
Jun 30
2009
Last Update
Oct 04
2011
Estimate

Drug Mitomycin-C 40 mg

Intravesical instillation of Mitomycin-C

  • Other names: Mytomicin-C Kyowa Italiana Farmaceutici Milano

transurethral resection alone No Intervention

Patients with non-muscle invasive bladder cancer who underwent transurethral resection alone;

intravesical mitomycin-C Active Comparator

Patients with non-muscle invasive bladder cancer who underwent one intravesical instillation of mitomycin-C immediately after transurethral resection

electromotive mitomycin-C Experimental

Patients with non-muscle invasive bladder cancer who underwent single immediate intravesical instillation of electromotive mitomycin-C immediately before transurethral resection

Criteria 

Inclusion Criteria:

All patients with primary histologically proven stage pTa-pT1 transitional-cell carcinoma of the bladder

Exclusion Criteria:

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
No Results Posted