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
  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. Bacillus Calmette-Guérin (BCG)

Condition Intervention Phase
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
Drug: Bacillus Calmette-Guérin
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor


Secondary Outcome Measures:
  • 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 ]

Enrollment: 190
Study Start Date: February 2002
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  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

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

No publications provided

Responsible Party: Medical Enterprises Europe B.V.
ClinicalTrials.gov Identifier: NCT00384891     History of Changes
Other Study ID Numbers: 102.1
Study First Received: October 5, 2006
Last Updated: October 5, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Medical Enterprises Europe B.V.:
Superficial urothelial cell carcinoma of bladder
NMIBC
Non Muscle Invasive Bladder Cancer
Hyperthermia
Bladder instillation
Mitomycin C
RITE
SHTC
Intravesical

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

ClinicalTrials.gov processed this record on October 22, 2014