Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Urinary Bladder Neoplasms

Hyperthermia

Urologic Neoplasms

Fever

Urologic Diseases

Urinary Bladder Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Antineoplastic Agents

All Drugs and Chemicals

Mitomycins

Mitomycin

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

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.

Synergo + MMC

Bacillus Calmette-Guérin

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

Medical Enterprises Europe B.V.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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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