Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG for Superficial Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Medical Enterprises Europe B.V..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Enterprises Europe B.V.
ClinicalTrials.gov Identifier:
NCT00384891
First received: October 5, 2006
Last updated: July 19, 2010
Last verified: July 2010
  Purpose

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. BCG

Condition Intervention Phase
Superficial Transitional Cell Carcinoma Therapy
(NMIBC = Non Muscle Invasive Bladder Cancer)
Device: Synergo
Drug: BCG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Medical Enterprises Europe B.V.:

Primary Outcome Measures:
  • Recurrence free survival, or [ Time Frame: 2 years ]
  • Time to complete response in CIS
  • Progression rate (to disease stage>T1) and/or metastatic disease

Secondary Outcome Measures:
  • Local and systemic side effects, both subjective and objective

Estimated Enrollment: 300
Study Start Date: February 2002
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synergo
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Device: Synergo
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Active Comparator: BCG
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
Drug: BCG
Intravesical instillation with BCG (Bacillus Calmette-Guérin)

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. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384891

Contacts
Contact: Yagel E Koren, MD +972-3-9244830 yagel@mel.co.il
Contact: Naama Reich, MSc +972-3-9244830 naamar@mel.co.il

Locations
Austria
University Hospital - AKH Vienna Recruiting
Vienna, Austria
Contact: Jörg Schmidbauer, MD    +43 (1) 40400 2616    joerg.schmidbauer@meduniwien.ac.at   
Principal Investigator: Jörg Schmidbauer, MD         
Belgium
Hospital Erasme Terminated
Brussels, Belgium
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Kochava Biton, RN    +972-4-8359283    kohava.biton@b-zion.org.il   
Principal Investigator: Ofer Nativ, MD         
Wolfson Hospital Suspended
Holon, Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel
Contact: Vladimir Yutkin, MD    +972-2-6776874    yutkin@hadassah.org.il   
Principal Investigator: Vladimir Yutkin, MD         
Italy
Galliera Hospital Recruiting
Genova, Italy
Contact: Fabio Campodonico, MD    +39-010-5632503    fabio.campodonico@galliera.it   
Principal Investigator: Massimo Maffezzini, MD         
Sub-Investigator: Fabio Campodonico, MD         
Sub-Investigator: Stefania Tamagno, RN         
San Raffaele Hospital (HSR) Recruiting
Milan, Italy
Contact: Anastasia Negro, Research Coordinator    +39-02- 26432422    negro.anastasia@hsr.it   
Principal Investigator: Renzo Colombo, MD         
Istituto Europeo del Oncologia Active, not recruiting
Milan, Italy
Policlinico Gemelli, Universita Cattolica del Sacro Cuore Withdrawn
Rome, Italy
Netherlands
Department of Urology, Radboud University Hospital Recruiting
Nijmegen, Netherlands
Contact: Jos Falke, MD    +31 24 3613920    J.Falke@uro.umcn.nl   
Contact: Rianne Lammers    +31 24 3613920    J.Lammers@uro.umcn.nl   
Principal Investigator: Alfred J Witjes, MD PhD         
Sub-Investigator: Jos Flake, MD         
Sub-Investigator: Rianne Lammers, MD         
Sponsors and Collaborators
Medical Enterprises Europe B.V.
Investigators
Principal Investigator: Alfred A Witjes, MD PhD Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Department, Medical Enterprises Israel
ClinicalTrials.gov Identifier: NCT00384891     History of Changes
Other Study ID Numbers: 102.1
Study First Received: October 5, 2006
Last Updated: July 19, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Medical Enterprises Europe B.V.:
Superficial transitional cell carcinoma of bladder
NMIBC
Non Muscle Invasive Bladder Cancer
Hyperthermia
Bladder instillation

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Fever
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Temperature Changes
Signs and Symptoms
Mitomycins
Mitomycin
BCG Vaccine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014