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

October 5, 2014 updated by: Medical Enterprises Europe B.V.

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • University Hospital - AKH Vienna
  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Center
      • Holon, Israel
        • Wolfson Hospital
      • Jerusalem, Israel
        • Hadassah University Hospital
  • Italy
      • Genova, Italy
        • Galliera Hospital
      • Milan, Italy
        • Istituto Europeo del Oncologia
      • Milan, Italy
        • San Raffaele Hospital (HSR)
  • Netherlands
      • Nijmegen, Netherlands
        • Department of Urology, Radboud University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synergo + MMC
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Device: Synergo + MMC
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Other Names:
  • RITE
  • SHTC
Active Comparator: Bacillus Calmette-Guérin
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Drug: Bacillus Calmette-Guérin
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Other Names:
  • BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: 2 years
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of complete response in CIS patients
Time Frame: 3 months
3 months
Progression rate (to disease stage>T1) and/or metastatic disease
Time Frame: 2 years
2 years
Local and systemic side effects, both subjective and objective
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Enterprises Europe B.V.

Investigators

  • Principal Investigator: Alfred A Witjes, MD PhD, Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria

October 5, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 5, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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