Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer (EMDA/PRE-TUR)
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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. |
- disease-free interval and recurrence rate [ Time Frame: recurrence assessed at 1 and 3 years from randomisation ] [ Designated as safety issue: Yes ]
- 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 |
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| Italy | |
| Dept. of Surgery, Tor Vergata University | |
| Rome, Italy, 00133 | |
| Principal Investigator: | Savino M Di Stasi, MD, PhD | "Tor Vergata" University, Rome, Italy |
More Information
Additional Information:
Publications:
| 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 Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Mitomycins Mitomycin |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |
ClinicalTrials.gov processed this record on May 23, 2013