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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00384891
Recruitment Status : Terminated (slow accrual)
First Posted : October 6, 2006
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Medical Enterprises Europe B.V.

Tracking Information
First Submitted Date  ICMJE October 5, 2006
First Posted Date  ICMJE October 6, 2006
Last Update Posted Date October 7, 2014
Study Start Date  ICMJE February 2002
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2014)
Recurrence free survival [ Time Frame: 2 years ]
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
  • Recurrence free survival, or
  • Time to complete response in CIS
  • Progression rate (to disease stage>T1) and/or metastatic disease
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
Local and systemic side effects, both subjective and objective
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
Official Title  ICMJE 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)
Brief Summary

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)
Detailed 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:

  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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Bladder Diseases
  • Urinary Bladder Neoplasms
  • Urinary Bladder Cancer
  • Malignant Tumor of Urinary Bladder
  • Urologic Diseases
  • Urologic Neoplasms
  • Neoplasms
  • Neoplasms by Site
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Arends TJ, Nativ O, Maffezzini M, de Cobelli O, Canepa G, Verweij F, Moskovitz B, van der Heijden AG, Witjes JA. Results of a Randomised Controlled Trial Comparing Intravesical Chemohyperthermia with Mitomycin C Versus Bacillus Calmette-Guérin for Adjuvant Treatment of Patients with Intermediate- and High-risk Non-Muscle-invasive Bladder Cancer. Eur Urol. 2016 Jun;69(6):1046-52. doi: 10.1016/j.eururo.2016.01.006. Epub 2016 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 5, 2014)
190
Original Enrollment  ICMJE
 (submitted: October 5, 2006)
300
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Israel,   Italy,   Netherlands
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT00384891
Other Study ID Numbers  ICMJE 102.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Enterprises Europe B.V.
Study Sponsor  ICMJE Medical Enterprises Europe B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alfred A Witjes, MD PhD Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands
PRS Account Medical Enterprises Europe B.V.
Verification Date October 2014

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