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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2013-12-31

Brief Summary

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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)

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Detailed Description

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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 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

Conditions

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Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Bladder Cancer Malignant Tumor of Urinary Bladder Urologic Diseases Urologic Neoplasms Neoplasms Neoplasms by Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Synergo + MMC

Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C

Group Type EXPERIMENTAL

Synergo + MMC

Intervention Type DEVICE

Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C

Bacillus Calmette-Guérin

Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Group Type ACTIVE_COMPARATOR

Bacillus Calmette-Guérin

Intervention Type DRUG

Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Interventions

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Synergo + MMC

Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C

Intervention Type DEVICE

Bacillus Calmette-Guérin

Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Intervention Type DRUG

Other Intervention Names

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RITE SHTC BCG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No