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

Primary Purpose

Urinary Bladder Diseases, Urinary Bladder Neoplasms, Urinary Bladder Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Synergo + MMC
Bacillus Calmette-Guérin
Sponsored by
Medical Enterprises Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Diseases focused on measuring Superficial urothelial cell carcinoma of bladder, NMIBC, Non Muscle Invasive Bladder Cancer, Hyperthermia, Bladder instillation, Mitomycin C, RITE, SHTC, Intravesical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital - AKH Vienna
  • Bnai Zion Medical Center
  • Wolfson Hospital
  • Hadassah University Hospital
  • Galliera Hospital
  • Istituto Europeo del Oncologia
  • San Raffaele Hospital (HSR)
  • Department of Urology, Radboud University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Synergo + MMC

Bacillus Calmette-Guérin

Arm Description

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

Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Outcomes

Primary Outcome Measures

Recurrence free survival
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor

Secondary Outcome Measures

Proportion of complete response in CIS patients
Progression rate (to disease stage>T1) and/or metastatic disease
Local and systemic side effects, both subjective and objective

Full Information

First Posted
October 5, 2006
Last Updated
October 5, 2014
Sponsor
Medical Enterprises Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00384891
Brief Title
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Enterprises Europe B.V.

4. Oversight

5. Study Description

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: A combination of bladder wall heating and local chemotherapy (Synergo) 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Diseases, Urinary Bladder Neoplasms, Urinary Bladder Cancer, Malignant Tumor of Urinary Bladder, Urologic Diseases, Urologic Neoplasms, Neoplasms, Neoplasms by Site
Keywords
Superficial urothelial cell carcinoma of bladder, NMIBC, Non Muscle Invasive Bladder Cancer, Hyperthermia, Bladder instillation, Mitomycin C, RITE, SHTC, Intravesical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synergo + MMC
Arm Type
Experimental
Arm Description
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Arm Title
Bacillus Calmette-Guérin
Arm Type
Active Comparator
Arm Description
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Intervention Type
Device
Intervention Name(s)
Synergo + MMC
Other Intervention Name(s)
RITE, SHTC
Intervention Description
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Intervention Type
Drug
Intervention Name(s)
Bacillus Calmette-Guérin
Other Intervention Name(s)
BCG
Intervention Description
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Primary Outcome Measure Information:
Title
Recurrence free survival
Description
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of complete response in CIS patients
Time Frame
3 months
Title
Progression rate (to disease stage>T1) and/or metastatic disease
Time Frame
2 years
Title
Local and systemic side effects, both subjective and objective
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred A Witjes, MD PhD
Organizational Affiliation
Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital - AKH Vienna
City
Vienna
Country
Austria
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Wolfson Hospital
City
Holon
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
Country
Israel
Facility Name
Galliera Hospital
City
Genova
Country
Italy
Facility Name
Istituto Europeo del Oncologia
City
Milan
Country
Italy
Facility Name
San Raffaele Hospital (HSR)
City
Milan
Country
Italy
Facility Name
Department of Urology, Radboud University Hospital
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26803476
Citation
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-Guerin 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.
Results Reference
derived

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

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