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Single Preoperative Intravesical Instillation of Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer: a Prospective Randomized Trial.


Phase 3
18 Years
90 Years
Not Enrolling
Both
Superficial Bladder Cancer

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Trial Information

Single Preoperative Intravesical Instillation of Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer: a Prospective Randomized Trial.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

disease-free interval and recurrence rate

Outcome Time Frame:

recurrence assessed at 1 and 3 years from randomisation

Safety Issue:

Yes

Principal Investigator

Savino M Di Stasi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

"Tor Vergata" University, Rome, Italy

Authority:

Italy: Ethics Committee

Study ID:

EMDA/PRE-TUR/691836

NCT ID:

NCT01149174

Start Date:

January 1994

Completion Date:

June 2009

Related Keywords:

  • Superficial Bladder Cancer
  • intravesical chemotherapy
  • early single instillation
  • mitomycin-C
  • electromotive drug administration
  • Urinary Bladder Neoplasms

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