Trials / Terminated
TerminatedNCT03335059
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.
A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guérin (BCG)-Unresponsive Patients With or Without Papillary NMIBC
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Medical Enterprises Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate (CRR) and disease-free duration for complete responders. The study will also explore progression-free survival time, bladder preservation rate, and overall survival time. The study will address an unmet need to identify a treatment effective in both ablating the disease and providing a prolonged disease-free period for patients. Ideally, the treatment will delay progression to invasive disease, thus preserving the bladder.
Conditions
- Bladder Cancer
- Bladder Neoplasm
- Bladder Tumors
- Cancer of Bladder
- Cancer of the Bladder
- Malignant Tumor of Urinary Bladder
- Neoplasms, Bladder
- Urinary Bladder Cancer
- Carcinoma in Situ of Bladder
- Papillary Carcinoma of Bladder (Diagnosis)
- BCG-Unresponsive Bladder Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Synergo® RITE + MMC | Subjects will receive a series of induction followed by a series of maintenance bladder instillations of Synergo® RITE + MMC |
Timeline
- Start date
- 2019-04-04
- Primary completion
- 2020-02-26
- Completion
- 2020-02-26
- First posted
- 2017-11-07
- Last updated
- 2020-04-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03335059. Inclusion in this directory is not an endorsement.