Intravesical Adjuvant Electromotive Mitomycin-C
Information source: University of Rome Tor Vergata
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bladder Cancer TNM Staging Primary Tumor (T) Ta; Bladder Cancer TNM Staging Primary Tumor (T) T1; Bladder Cancer Transitional Cell Grade
Intervention: Trans-urethral resection (Procedure); intravesical passive diffusion mitomycin (Drug); intravesical electromotive mitomycin (Device)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Rome Tor Vergata Official(s) and/or principal investigator(s): Savino M Di Stasi, MD, PhD, Principal Investigator, Affiliation: Tor Vergata University, Rome, Italy
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.
Clinical Details
Official title: Intravesical Adjuvant Electromotive Mitomycin-C in Patients With pTa-pT1 and G1-G2 Non-muscle Invasive Bladder Cancer: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Disease-free interval
Secondary outcome: Time to progression
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- histologically proven primary stage pTa-pT1 urothelial bladder cancer,
- adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L;
platelet count ≥120 × 10⁹/L),
- normal renal function (ie, serum creatinine ≤123·76 μmol/L),
- normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum
glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L),
- Eastern Cooperative Oncology Group performance status between 0 and 2.
Exclusion Criteria:
- non-urothelial carcinomas of the bladder;
- previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder;
- urothelial carcinoma of the upper urinary tract and urethra, or both;
- previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs;
- known allergy to mitomycin;
- bladder capacity less than 200 mL;
- untreated urinary-tract
- infection; severe systemic infection (ie, sepsis);
- treatment with immunosuppressive drugs;
- urethral strictures that would prevent endoscopic procedures and catheterisation;
- previous radiotherapy to the pelvis;
- other concurrent chemo therapy, radio therapy, and treatment with biological response
modifiers;
- other malignant diseases within 5 years of trial registration (except for adequately
treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
- pregnancy;
- any factors that would preclude study participation.
Locations and Contacts
Tor Vergata University, Department of experimental Medicine and Surgery/Urology, Rome, RM 00133, Italy
Additional Information
Starting date: January 1994
Last updated: August 8, 2013
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