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

Phase 3

Completed

• Conditions: Superficial Bladder Cancer
• Interventions: Drug: Mitomycin-C 40 mg

• Registration Number: NCT01149174
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-01
• Primary Completion: 2003-12
• Study Completion: 2009-06
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-03
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravesical mitomycin-C	Mitomycin-C 40 mg	Patients with non-muscle invasive bladder cancer who underwent one intravesical instillation of mitomycin-C immediately after transurethral resection
electromotive mitomycin-C	Mitomycin-C 40 mg	Patients with non-muscle invasive bladder cancer who underwent single immediate intravesical instillation of electromotive mitomycin-C immediately before transurethral resection

Primary Outcome Measures

Name	Time	Method
disease-free interval and recurrence rate	recurrence assessed at 1 and 3 years from randomisation

Secondary Outcome Measures

Name	Time	Method
disease progression and overall and specific disease mortality	progression and mortality assessed at 5 years from randomisation

Trial Locations

Locations (1)

Dept. of Surgery, Tor Vergata University; 🇮🇹 Rome, Italy