Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer

Launched by MEDICAL ENTERPRISES EUROPE B.V. · Oct 5, 2006

Keywords

ClinConnect Summary

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. Bacillus Calmette-Guérin (BCG)

Patients will be treated during the first year of the study, and will be foll...

Gender

ALL

Eligibility criteria

• 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