SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I (SHTC-EUROPE-1)
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|ClinicalTrials.gov Identifier: NCT02254915|
Recruitment Status : Withdrawn (Shortages of the active comparator drug (BCG) on the market worldwide and a growing uncertainty as to its future supply.)
First Posted : October 2, 2014
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases||Device: Synergo + MMC Drug: Bacillus Calmette-Guérin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Estimated Primary Completion Date :||January 2020|
Experimental: Synergo + MMC
Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy (SHTC) with mitomycin C (RITE) intravesical therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,
Device: Synergo + MMC
Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system.
Active Comparator: Bacillus Calmette-Guérin
Intravesical BCG therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,
Drug: Bacillus Calmette-Guérin
Intravesical instillation of BCG.
Other Name: BCG
- RFS time [ Time Frame: 2 years ]The recurrence-free survival time in patients with NMIBC following treatment with SHTC (investigational arm) compared to BCG (controlled arm).
- Progression-free survival time [ Time Frame: 2 years ]
- Recurrence free survival time by risk group [ Time Frame: 2 years ]
- Organ preservation rate [ Time Frame: 2 years ]
- Overall survival time [ Time Frame: 2 years ]
- Disease-specific survival time [ Time Frame: 2 years ]
- Adverse events [ Time Frame: 2 years ]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.
- Treatment discontinuation [ Time Frame: 2 years ]Proportion of treatment discontinuation of SHTC compared to BCG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254915
|Study Director:||Igal Ruvinsky, PhD||Medical Enterprises Europe B.V.|
|Principal Investigator:||Gerson Luedecke, Dr. med.||Universitätsklinikum Gießen und Marburg|