Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer
NCT ID: NCT01149174
Last Updated: 2011-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
352 participants
INTERVENTIONAL
1994-01-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
transurethral resection alone
Patients with non-muscle invasive bladder cancer who underwent transurethral resection alone;
No interventions assigned to this group
intravesical mitomycin-C
Patients with non-muscle invasive bladder cancer who underwent one intravesical instillation of mitomycin-C immediately after transurethral resection
Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C
electromotive mitomycin-C
Patients with non-muscle invasive bladder cancer who underwent single immediate intravesical instillation of electromotive mitomycin-C immediately before transurethral resection
Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Rome Tor Vergata
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Savino M. Di Stasi
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Savino M Di Stasi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
"Tor Vergata" University, Rome, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept. of Surgery, Tor Vergata University
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/S1470-2045(11)70190-5. Epub 2011 Aug 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EMDA/PRE-TUR/691836
Identifier Type: -
Identifier Source: org_study_id