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

NCT01149174 | Completed Phase 3 DMC

• 1 other identifier: EMDA/PRE-TUR/691836
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Superficial Bladder Cancer

Keywords

intravesical chemotherapy; early single instillation; mitomycin-C; electromotive drug administration

Outcome Measures

Primary Outcomes (1)

• disease-free interval and recurrence rate

  recurrence assessed at 1 and 3 years from randomisation

Secondary Outcomes (1)

• disease progression and overall and specific disease mortality

  progression and mortality assessed at 5 years from randomisation

Study Arms (3)

transurethral resection alone

NO INTERVENTION

Patients with non-muscle invasive bladder cancer who underwent transurethral resection alone;

intravesical mitomycin-C

ACTIVE COMPARATOR

Patients with non-muscle invasive bladder cancer who underwent one intravesical instillation of mitomycin-C immediately after transurethral resection

Drug: Mitomycin-C 40 mg

electromotive mitomycin-C

EXPERIMENTAL

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

Interventions

Mitomycin-C 40 mg DRUG

Intravesical instillation of Mitomycin-C

Also known as: Mytomicin-C Kyowa Italiana Farmaceutici Milano

electromotive mitomycin-C; intravesical mitomycin-C

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with primary histologically proven stage pTa-pT1 transitional-cell carcinoma of the bladder

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Dept. of Surgery, Tor Vergata University

Rome, 00133, Italy

Location

Related Publications (3)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 21831711 RESULT

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Savino M Di Stasi, MD, PhD

  "Tor Vergata" University, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: June 23, 2010
• Study Start: January 1, 1994
• Primary Completion: December 1, 2003
• Study Completion: June 1, 2009
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

IT (1)