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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 18, 2009

Last Updated Date

October 3, 2011

Start Date ^ICMJE

January 1994

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

disease-free interval and recurrence rate [ Time Frame: recurrence assessed at 1 and 3 years from randomisation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01149174 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

disease progression and overall and specific disease mortality [ Time Frame: progression and mortality assessed at 5 years from randomisation ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

disease progression and overall and specific disease mortality [ Time Frame: proogression and mortality assessed at 5 years from randomisation ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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, 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Superficial Bladder Cancer

Intervention ^ICMJE

Drug: Mitomycin-C 40 mg

Intravesical instillation of Mitomycin-C

Other Name: Mytomicin-C Kyowa Italiana Farmaceutici Milano

Study Arm (s)

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

Publications *

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 Oncology, 2010 ASCO Annual Meeting Proceedings. Vol 28, No 15 Suppl (May 20 Supplement), 2010: Abs # 4543.
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 Annual Meeting Proceedings. Vol 183, No. 4 Suppl (April Supplement), 2010: Abs #1346.
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 bladder cancer: a randomised controlled trial. Lancet Oncol. 2011 Sep;12(9):871-9. Epub 2011 Aug 8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

352

Completion Date

June 2009

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01149174

Other Study ID Numbers ^ICMJE

EMDA/PRE-TUR/691836

Has Data Monitoring Committee

Yes

Responsible Party

Savino M. Di Stasi, University of Rome Tor Vergata

Study Sponsor ^ICMJE

University of Rome Tor Vergata

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Savino M Di Stasi, MD, PhD

"Tor Vergata" University, Rome, Italy

Information Provided By

University of Rome Tor Vergata

Verification Date

October 2011

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

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