Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Medical Enterprises Europe B.V.
ClinicalTrials.gov Identifier:
NCT00384891
First received: October 5, 2006
Last updated: October 5, 2014
Last verified: October 2014

October 5, 2006
October 5, 2014
February 2002
December 2013   (final data collection date for primary outcome measure)
Recurrence free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
  • Recurrence free survival, or
  • Time to complete response in CIS
  • Progression rate (to disease stage>T1) and/or metastatic disease
Complete list of historical versions of study NCT00384891 on ClinicalTrials.gov Archive Site
  • Proportion of complete response in CIS patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Progression rate (to disease stage>T1) and/or metastatic disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Local and systemic side effects, both subjective and objective [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Local and systemic side effects, both subjective and objective
Not Provided
Not Provided
 
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
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)

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)

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
    Other Names:
    • RITE
    • SHTC
  • Drug: Bacillus Calmette-Guérin
    Intravesical instillation with BCG (Bacillus Calmette-Guérin)
    Other Name: BCG
  • Experimental: Synergo + MMC
    Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
    Intervention: Device: Synergo + MMC
  • Active Comparator: Bacillus Calmette-Guérin
    Intravesical instillation with BCG (Bacillus Calmette-Guérin)
    Intervention: Drug: Bacillus Calmette-Guérin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
190
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Israel,   Italy,   Netherlands
Belgium
 
NCT00384891
102.1
Not Provided
Medical Enterprises Europe B.V.
Medical Enterprises Europe B.V.
Not Provided
Principal Investigator: Alfred A Witjes, MD PhD Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands
Medical Enterprises Europe B.V.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP