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

Medicals International

Status and phase

Terminated

Phase 3

Conditions

Urinary Bladder Cancer

Malignant Tumor of Urinary Bladder

Urinary Bladder Diseases

Urinary Bladder Neoplasms

Neoplasms by Site

Neoplasms

Urologic Neoplasms

Urologic Diseases

Treatments

Drug: Bacillus Calmette-Guérin

Device: Synergo + MMC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384891

102.1

Details and patient eligibility

About

The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer:

A combination of bladder wall heating and local chemotherapy (Synergo)
Bacillus Calmette-Guérin (BCG)

Full 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 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:

A combination of bladder wall heating and local chemotherapy (Synergo)
Bacillus Calmette-Guérin (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

Enrollment

190 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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