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

Condition(s) targeted: Superficial Transitional Cell Carcinoma Therapy; (NMIBC = Non Muscle Invasive Bladder Cancer)

Intervention: Synergo (Device); BCG (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Medical Enterprises Europe B.V.

Official(s) and/or principal investigator(s):
Alfred A Witjes, MD PhD, Principal Investigator, Affiliation: Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands

Overall contact:
Yagel E Koren, MD, Phone: +972-3-9244830, Email: yagel@mel.co.il

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

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Recurrence free survival, or

Time to complete response in CIS

Progression rate (to disease stage>T1) and/or metastatic disease

Secondary outcome: Local and systemic side effects, both subjective and objective

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Yagel E Koren, MD, Phone: +972-3-9244830, Email: yagel@mel.co.il

University Hospital - AKH Vienna, Vienna, Austria; Recruiting
Jörg Schmidbauer, MD, Phone: +43 (1) 40400 2616, Email: joerg.schmidbauer@meduniwien.ac.at
Jörg Schmidbauer, MD, Principal Investigator

Hospital Erasme, Brussels, Belgium; Terminated

Bnai Zion Medical Center, Haifa, Israel; Recruiting
Kochava Biton, RN, Phone: +972-4-8359283, Email: kohava.biton@b-zion.org.il
Ofer Nativ, MD, Principal Investigator

Wolfson Hospital, Holon, Israel; Suspended

Hadassah University Hospital, Jerusalem, Israel; Recruiting
Vladimir Yutkin, MD, Phone: +972-2-6776874, Email: yutkin@hadassah.org.il
Vladimir Yutkin, MD, Principal Investigator

Galliera Hospital, Genova, Italy; Recruiting
Fabio Campodonico, MD, Phone: +39-010-5632503, Email: fabio.campodonico@galliera.it
Massimo Maffezzini, MD, Principal Investigator
Fabio Campodonico, MD, Sub-Investigator
Stefania Tamagno, RN, Sub-Investigator

San Raffaele Hospital (HSR), Milan, Italy; Recruiting
Anastasia Negro, Research Coordinator, Phone: +39-02- 26432422, Email: negro.anastasia@hsr.it
Renzo Colombo, MD, Principal Investigator

Istituto Europeo del Oncologia, Milan, Italy; Active, not recruiting

Policlinico Gemelli, Universita Cattolica del Sacro Cuore, Rome, Italy; Withdrawn

Department of Urology, Radboud University Hospital, Nijmegen, Netherlands; Recruiting
Jos Falke, MD, Phone: +31 24 3613920, Email: J.Falke@uro.umcn.nl
Rianne Lammers, Phone: +31 24 3613920, Email: J.Lammers@uro.umcn.nl
Alfred J Witjes, MD PhD, Principal Investigator
Jos Flake, MD, Sub-Investigator
Rianne Lammers, MD, Sub-Investigator

Clinical study page at medical-enterprises.com

Starting date: February 2002
Last updated: July 19, 2010