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. (RITE-USA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03335059|
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : January 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Combination Product: Synergo® RITE + MMC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||January 2025|
Experimental: Synergo® RITE + MMC
Bladder radiofrequency-induced hyperthermia will be delivered in combination with each instillation of MMC in accordance with the Sponsor operational guidelines.
Combination Product: Synergo® RITE + MMC
Subjects will receive a series of induction followed by a series of maintenance bladder instillations of Synergo® RITE + MMC
- complete response rate (CRR) [ Time Frame: 3 months after the initiation of study therapy ]
- no CIS
- no papillary HG tumor
- no papillary T1 tumor
- no extra-vesical UC tumor
- no progression a patient will be considered a complete responder only if all the criteria above are met.
- disease-free duration of complete response (DCR) [ Time Frame: through study completion, up to 33 months ]time of recurrence for complete response patients from the 3-month visit until the time of recurrence or until the last follow-up, whichever occurs sooner.
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): NCT03335059
|Contact: Igal Ruvinsky, PhD||+972 (3) 924 48 30 ext email@example.com|
|Contact: Avigdor Lev, PhD||+31(20) firstname.lastname@example.org|
|United States, California|
|Tower Urology||Not yet recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Shiblee Nomanee 310-854-9898 ext 168 email@example.com|
|Principal Investigator: Premal Desai, MD|
|United States, Maryland|
|Chesapeake Urology Research Associates||Not yet recruiting|
|Hanover, Maryland, United States, 21076|
|Contact: Wendy Paxton 443-471-5763 firstname.lastname@example.org|
|Principal Investigator: Rian Dickstein, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Hanna Stambakio 215-614-5039 email@example.com|
|Principal Investigator: S Bruce Malkowicz, MD|
|Study Director:||Igal Ruvinsky, PhD||Medical Enterprises Ltd.|