A Randomized Controlled Study Comparing Adjuvant Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG Immunotherapy (BCG) Adjuvant Treatment in Patients With Superficial Transitional Cell Carcinoma of the Bladder (STCCB)
18 Years
N/A
Both
Superficial Transitional Cell Carcinoma Therapy, (NMIBC = Non Muscle Invasive Bladder Cancer)
Trial Information
A Randomized Controlled Study Comparing Adjuvant Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG Immunotherapy (BCG) Adjuvant Treatment in Patients With Superficial Transitional Cell Carcinoma of the Bladder (STCCB)
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 have their tumors surgically resected prior to study enrollment, and undergo a
series of tests to prove their bladder is now free of tumor. Eligible patients will be
randomly assigned to one of 2 treatment arms:
1. A combination of bladder wall heating and local chemotherapy (Synergo)
2. BCG
Patients will be treated during the first year of the study, and will be followed up for a
total of 2 years. The follow up will include a visual evaluation of the patient's bladder by
cystoscopy, a cytological examination of the urine (to look for malignant cells) and other
additional exams. The patients' general welfare will be monitored through out the study.
The aim of this study is to compare the efficacy and safety of the novel treatment (Synergo)
to that of the well-known BCG
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recurrence free survival, or
Outcome Time Frame:
2 years
Principal Investigator
Alfred A Witjes, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands
Authority:
Israel: Ministry of Health
Study ID:
102.1
NCT ID:
NCT00384891
Start Date:
February 2002
Completion Date:
December 2013
Related Keywords:
- Superficial Transitional Cell Carcinoma Therapy
- (NMIBC = Non Muscle Invasive Bladder Cancer)
- Superficial transitional cell carcinoma of bladder
- NMIBC
- Non Muscle Invasive Bladder Cancer
- Hyperthermia
- Bladder instillation
- Urinary Bladder Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
- Fever
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