Trials / Withdrawn
WithdrawnNCT02254915
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)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Medical Enterprises Europe B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Urinary Bladder Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms
- Neoplasms by Site
- Urinary Bladder Diseases
- Urologic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Synergo + MMC | Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system. |
| DRUG | Bacillus Calmette-Guérin | Intravesical instillation of BCG. |
Timeline
- Primary completion
- 2020-01-01
- First posted
- 2014-10-02
- Last updated
- 2015-04-01
Source: ClinicalTrials.gov record NCT02254915. Inclusion in this directory is not an endorsement.