Intravesical Adjuvant Electromotive Mitomycin-C
Condition: Bladder Cancer TNM Staging Primary Tumor (T) Ta; Bladder Cancer TNM Staging Primary Tumor (T) T1; Bladder Cancer Transitional Cell Grade
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In laboratory and clinical studies, intravesical electromotive drug administration increased
      mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive
      urothelial bladder cancer. The investigators' aim was to compare transurethral resection of
      bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection
      and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in
      patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will
      be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant
      intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over
      60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40
      mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric
      current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant
      electromotive and passive diffusion mitomycin groups who are disease-free 3 months after
      induction treatment, will be scheduled to receive monthly intravesical instillation for 10
      months, with the same dose and methods of infusion as initial assigned treatment. All
      patients will be assessed for safety. The investigators' primary endpoints are recurrence
      rate and disease-free interval. Analyses will be done by intention to treat.
    


Intervention name(s): Trans-urethral resection; intravesical passive diffusion mitomycin; intravesical electromotive mitomycin
Intervention type(s): Procedure; Drug; Device
Intervention description(s): Patients underwent urinary cytology of the bladder and upper urinary tract; random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples.; A dose of 40 mg mitomycin dissolved in 50 ml sterile water is infused intravesically through a Foley catheter, retained in the bladder for 60 min with catheter clamping, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations, with the same dose and methods of infusion as initial assigned treatment.; A dose of 40 mg mitomycin dissolved in 100 ml water is instilled and retained in the bladder for 30 minutes with 20 mA pulsed electric current, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations with the same dose and methods of infusion as initial assigned treatment. Intravesical electromotive drug administration is given by a battery-powered generator delivering a controlled electric current that passes between the active intravesical electrode (integrated into a specific transurethral catheter) and dispersive ground electrodes (on skin of the lower abdomen). Operators set active electrode polarity and current intensity on the generator.
Other intervention name(s): Mitomycin-C
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-muscle invasive bladder cancer; intravesical chemotherapy; mitomycin; passive diffusion; electromotive drug administration