Status:
COMPLETED
Intravesical Adjuvant Electromotive Mitomycin-C
Lead Sponsor:
University of Rome Tor Vergata
Collaborating Sponsors:
University of L'Aquila
University Of Perugia
Conditions:
Bladder Cancer TNM Staging Primary Tumor (T) Ta
Bladder Cancer TNM Staging Primary Tumor (T) T1
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01920269
Start Date
January 1 1994
End Date
June 1 2013
Last Update
August 9 2013
Active Locations (1)
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1
Tor Vergata University, Department of experimental Medicine and Surgery/Urology
Rome, RM, Italy, 00133