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

Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Synergo + MMC

Bacillus Calmette-Guérin

Alfred A Witjes, MD PhD

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)

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

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

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)

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

Medical Enterprises Europe B.V.

Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy (SHTC) with mitomycin C (RITE) intravesical therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,

Intravesical BCG therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,

Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system.

Igal Ruvinsky, PhD

Gerson Luedecke, Dr. med.

A multi-institutional, prospective, randomised, open-label, superiority, comparative, active-controlled, phase 3 study. The study will compare Synergo RF-induced hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC, and will evaluate recurrence and progression rate over two years of follow-up.

SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I

A Multi-Centre, Randomised, Open-Label Active-Controlled Study Comparing Safety and Efficacy of Synergo Radiofrequency (RF)-Induced Hyperthermia-Chemotherapy With Mitomycin C (RITE) Versus Bacillus Calmette-Guérin (BCG) as First-Line Treatment of Non-Muscle Invasive Papillary Bladder Cancer (NMIBC)

The recurrence-free survival time in patients with NMIBC following treatment with SHTC (investigational arm) compared to BCG (controlled arm).

Safety (rate of adverse events), as well as tolerability of SHTC compared to BCG in terms of the frequency, severity and nature of adverse events and the treatment received.

Proportion of treatment discontinuation of SHTC compared to BCG

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer	NCT00384891	Urinary Bladder... Urinary Bladder... Urinary Bladder... Malignant Tumor... Urologic Diseas... Urologic Neopla... Neoplasms Neoplasms by Si...	Synergo + MMC Bacillus Calmet...	18 Years -	Medical Enterprises Europe B.V.
SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I	NCT02254915	Urinary Bladder... Urologic Neopla... Urogenital Neop... Neoplasms Neoplasms by Si... Urinary Bladder... Urologic Diseas...	Synergo + MMC Bacillus Calmet...	18 Years -	Medical Enterprises Europe B.V.
SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I	NCT02254915	Urinary Bladder... Urologic Neopla... Urogenital Neop... Neoplasms Neoplasms by Si... Urinary Bladder... Urologic Diseas...	Synergo + MMC Bacillus Calmet...	18 Years -	Medical Enterprises Europe B.V.

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