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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Superficial Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Surgery, Tor Vergata University

Rome, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitomycin-C 40 mg

Drug

Intravesical instillation of Mitomycin-C

Other names: Mytomicin-C Kyowa Italiana Farmaceutici Milano

Primary outcomes

disease-free interval and recurrence rate

Time frame: recurrence assessed at 1 and 3 years from randomisation

Secondary outcomes

disease progression and overall and specific disease mortality

Time frame: progression and mortality assessed at 5 years from randomisation

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Acronym: EMDA/PRE-TUR

Important dates

Study start: 1994
Primary completion: 2003
Study completion: 2009
First posted: Jun 23, 2010
Registry last updated: Oct 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed