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

October 3, 2011 updated by: Savino M. Di Stasi, University of Rome Tor Vergata

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Dept. of Surgery, Tor Vergata University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C
Other Names:
  • Mytomicin-C Kyowa Italiana Farmaceutici Milano
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
Drug: Mitomycin-C 40 mg
Intravesical instillation of Mitomycin-C
Other Names:
  • Mytomicin-C Kyowa Italiana Farmaceutici Milano

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free interval and recurrence rate
Time Frame: recurrence assessed at 1 and 3 years from randomisation
recurrence assessed at 1 and 3 years from randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
disease progression and overall and specific disease mortality
Time Frame: progression and mortality assessed at 5 years from randomisation
progression and mortality assessed at 5 years from randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Savino M Di Stasi, MD, PhD, "Tor Vergata" University, Rome, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Primary Completion (ACTUAL)

December 1, 2003

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

June 22, 2010

First Posted (ESTIMATE)

June 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 3, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMDA/PRE-TUR/691836

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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