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

Trial end date:
Target enrollment:
Participant gender:
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 chemotherapy (Synergo) 2. Bacillus Calmette-Guérin (BCG)
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
Medical Enterprises Europe B.V.
BCG Vaccine
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