Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
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| ClinicalTrials.gov Identifier: NCT00384891 |
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Recruitment Status
:
Terminated
(slow accrual)
First Posted
: October 6, 2006
Last Update Posted
: October 7, 2014
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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:
- A combination of bladder wall heating and local chemotherapy (Synergo)
- Bacillus Calmette-Guérin (BCG)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Bladder Cancer Malignant Tumor of Urinary Bladder Urologic Diseases Urologic Neoplasms Neoplasms Neoplasms by Site | Device: Synergo + MMC Drug: Bacillus Calmette-Guérin | Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 190 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | February 2002 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Synergo + MMC
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
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Device: Synergo + MMC
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Other Names:
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Active Comparator: Bacillus Calmette-Guérin
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
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Drug: Bacillus Calmette-Guérin
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Other Name: BCG
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- Recurrence free survival [ Time Frame: 2 years ]Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
- Proportion of complete response in CIS patients [ Time Frame: 3 months ]
- Progression rate (to disease stage>T1) and/or metastatic disease [ Time Frame: 2 years ]
- Local and systemic side effects, both subjective and objective [ Time Frame: 2 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384891
| Austria | |
| University Hospital - AKH Vienna | |
| Vienna, Austria | |
| Israel | |
| Bnai Zion Medical Center | |
| Haifa, Israel | |
| Wolfson Hospital | |
| Holon, Israel | |
| Hadassah University Hospital | |
| Jerusalem, Israel | |
| Italy | |
| Galliera Hospital | |
| Genova, Italy | |
| Istituto Europeo del Oncologia | |
| Milan, Italy | |
| San Raffaele Hospital (HSR) | |
| Milan, Italy | |
| Netherlands | |
| Department of Urology, Radboud University Hospital | |
| Nijmegen, Netherlands | |
| Principal Investigator: | Alfred A Witjes, MD PhD | Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Enterprises Europe B.V. |
| ClinicalTrials.gov Identifier: | NCT00384891 History of Changes |
| Other Study ID Numbers: |
102.1 |
| First Posted: | October 6, 2006 Key Record Dates |
| Last Update Posted: | October 7, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Medical Enterprises Europe B.V.:
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Superficial urothelial cell carcinoma of bladder NMIBC Non Muscle Invasive Bladder Cancer Hyperthermia Bladder instillation |
Mitomycin C RITE SHTC Intravesical |
Additional relevant MeSH terms:
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Neoplasms Urinary Bladder Neoplasms Fever Neoplasms by Site Urologic Diseases Urinary Bladder Diseases Urologic Neoplasms Urogenital Neoplasms Body Temperature Changes Signs and Symptoms Mitomycins |
Mitomycin BCG Vaccine Antibiotics, Antineoplastic Antineoplastic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |