Status:
COMPLETED
Sequential Bacillus Calmette-Guérin (BCG) and Electromotive Mitomycin-C Versus Bacillus Calmette-Guérin (BCG) Alone for High Risk Superficial Bladder Cancer
Lead Sponsor:
University of Rome Tor Vergata
Collaborating Sponsors:
University of L'Aquila
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Intravesical treatment for superficial bladder cancer has been used for the past 4-5 decades. Intravesical chemotherapy is beneficial in terms of recurrence and time to recurrence in grade 1-2 stage T...
Detailed Description
All patients with histologically proven stage pT1 urothelial carcinoma of the bladder, whether papillary or solid, are regarded as being at high risk for tumour recurrence and at moderate to high risk...
Eligibility Criteria
Inclusion
- adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 x106 cells/L and platelet count ≥120 x 109/L)
- normal renal function (ie, serum creatinine ≤123•76 μmol/L)
- normal liver function (ie, serum glutamic-oxaloacetic transaminase ≤42 U/L, serum glutamic-pyruvic transaminase ≤48 U/L, and total bilirubin ≤22•23 μmol/L)
- Karnofsky performance status between 50 and 100.
Exclusion
- previous treatment with BCG or electromotive mitomycin
- treatment with any other intravesical cytostatic agent within the past 6 months
- concomitant urothelial tumours of the upper urinary tract;
- previous muscle-invasive (ie, stage T2 or higher) transitional-cell - carcinoma of the bladder
- bladder capacity less than 2 L
- untreated urinary-tract infection
- severe systemic infection (ie, sepsis)
- urethral strictures that would prevent endoscopic procedures and repeated catheterisation
- disease of upper urinary tract (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk
- previous radiotherapy to the pelvis
- other concurrent chemotherapy
- treatment with radiotherapy-response or biological-response modifiers;
- history of tuberculosis
- other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma)
- pregnancy or nursing
- psychological, familial, sociological, or geographical factors that would preclude study participation.
Key Trial Info
Start Date :
January 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01442519
Start Date
January 1 1994
End Date
June 1 2002
Last Update
September 28 2011
Active Locations (1)
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1
Dept. of Surgery/Urology, Tor Vergata University
Rome, RM, Italy, 00133