Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer (EMDA/PRE-TUR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Savino M. Di Stasi, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT01149174
First received: November 18, 2009
Last updated: October 3, 2011
Last verified: October 2011

November 18, 2009
October 3, 2011
January 1994
December 2003   (final data collection date for primary outcome measure)
disease-free interval and recurrence rate [ Time Frame: recurrence assessed at 1 and 3 years from randomisation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01149174 on ClinicalTrials.gov Archive Site
disease progression and overall and specific disease mortality [ Time Frame: progression and mortality assessed at 5 years from randomisation ] [ Designated as safety issue: Yes ]
disease progression and overall and specific disease mortality [ Time Frame: proogression and mortality assessed at 5 years from randomisation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Superficial Bladder Cancer
Drug: Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C
Other Name: Mytomicin-C Kyowa Italiana Farmaceutici Milano
  • No Intervention: transurethral resection alone
    Patients with non-muscle invasive bladder cancer who underwent transurethral resection alone;
  • Active Comparator: intravesical mitomycin-C
    Patients with non-muscle invasive bladder cancer who underwent one intravesical instillation of mitomycin-C immediately after transurethral resection
    Intervention: Drug: Mitomycin-C 40 mg
  • Experimental: electromotive mitomycin-C
    Patients with non-muscle invasive bladder cancer who underwent single immediate intravesical instillation of electromotive mitomycin-C immediately before transurethral resection
    Intervention: Drug: Mitomycin-C 40 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
June 2009
December 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01149174
EMDA/PRE-TUR/691836
Yes
Savino M. Di Stasi, University of Rome Tor Vergata
University of Rome Tor Vergata
Not Provided
Principal Investigator: Savino M Di Stasi, MD, PhD "Tor Vergata" University, Rome, Italy
University of Rome Tor Vergata
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP