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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
  Purpose

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.


Condition Intervention Phase
Superficial Bladder Cancer
Drug: Mitomycin-C 40 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Single Preoperative Intravesical Instillation of Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer: a Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by University of Rome Tor Vergata:

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

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

Enrollment: 352
Study Start Date: January 1994
Study Completion Date: June 2009
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Mytomicin-C Kyowa Italiana Farmaceutici Milano

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149174

Locations
Italy
Dept. of Surgery, Tor Vergata University
Rome, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
Principal Investigator: Savino M Di Stasi, MD, PhD "Tor Vergata" University, Rome, Italy
  More Information

Additional Information:
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.

Responsible Party: Savino M. Di Stasi, Professor, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01149174     History of Changes
Other Study ID Numbers: EMDA/PRE-TUR/691836
Study First Received: November 18, 2009
Last Updated: October 3, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Rome Tor Vergata:
intravesical chemotherapy
early single instillation
mitomycin-C
electromotive drug administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014