Status:
TERMINATED
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
Lead Sponsor:
Medical Enterprises Europe B.V.
Conditions:
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: 1. A combination of bladder wall heating and local ...
Detailed Description
The study is a randomized controlled study, designed to test the efficacy and safety of a new treatment modality for the prevention of tumor recurrence in superficial bladder cancer. Patients must ha...
Eligibility Criteria
Inclusion
- Superficial TCC: Any G3 or any T1 and/or CIS
- Multifocal (\>1) Ta lesions
- Multiple recurrences (\>2) of Ta lesions in the last 24 months
- Complete tumor eradication must be confirmed
- WHO performance status 0-2 (Appendix V)
- Life expectancy of more than 24 months
- Patients willing to sign informed consent
Exclusion
- Bladder tumors other than TCC
- Coexistence of another primary malignant tumor other than BCC of the skin
- TCC of the bladder involving the urethra or upper urinary tract
- Previous history of TCC stage T2 or higher
- Clinical presence or previous history of regional spreading or distant metastases
- Intravesical MMC treatments during the last 12 months
- Previous intravesical BCG therapy (Any intravesical BCG therapy in the last 24 months, or More than 6 BCG intravesical instillations in the last 48 months.
- Previous pelvic radiotherapy or systemic chemotherapy
- Partial cystectomy
- Diverticle of bladder larger than 1cm in diameter
- Residual urine \> 100cc measured by uroflowmetry
- Bladder volume \< 150cc measured by ultrasound
- Urinary incontinence (more than one wet pad a day)
- Urethral stricture impeding 20F catheterization
- Urethral bleeding or persistent hematuria
- Active intractable or uncontrollable UTI
- Active tuberculosis or BCG infection
- Patients who experienced BCG life threatening sepsis
- Known allergy to MMC or BCG
- Known impaired immune response, positive HIV serology, patients receiving systemic steroids or immunosuppressive therapy
- Hematological disorders; leukocytes \< 3500, platelets \< 100,000
- Kidney or liver function disorders (more than 1.5 times upper normal limit)
- Pregnant or lactating women
- Patients who cannot be followed up properly or are unable to collaborate
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00384891
Start Date
February 1 2002
End Date
December 1 2013
Last Update
October 7 2014
Active Locations (8)
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1
University Hospital - AKH Vienna
Vienna, Austria
2
Bnai Zion Medical Center
Haifa, Israel
3
Wolfson Hospital
Holon, Israel
4
Hadassah University Hospital
Jerusalem, Israel