Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer

Superficial Bladder Cancer Clinical Trial

— EMDA/PRE-TUR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149174
• Other study ID #: EMDA/PRE-TUR/691836
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2009
• Last updated: October 3, 2011
• Start date: January 1994
• Est. completion date: June 2009

Study information

• Verified date: October 2011
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: June 2009
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Superficial Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C

Locations

Country	Name	City	State
Italy	Dept. of Surgery, Tor Vergata University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Di Stasi SM, Valenti M, Verri C, Liberati E, Giurioli A, Leprini G, Masedu F, Ricci AR, Micali F, Vespasiani G. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bla — View Citation

Di Stasi SM, Verri C, Capelli G, Brausi M , Leprini G, Casilio M, Zampa G. Single preoperative intravesical instillation of electromotive mitomycin-C for primary non- muscle-invasive bladder cancer: A prospective randomized trial. Journal of Clinical Onco

Di Stasi SM, Verri C, Capelli G, Brausi M, Leprini G, G Zampa, Stephen RL. Single preoperative intravesical instillation of electromotive mitomycin-C for primary non-muscle invasive bladder cancer: A randomized trial. The Journal of Urology, 2010 AUA Annu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free interval and recurrence rate		recurrence assessed at 1 and 3 years from randomisation	Yes
Secondary	disease progression and overall and specific disease mortality		progression and mortality assessed at 5 years from randomisation	Yes

External Links

•   2010 ASCO Annual Meeting.