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)
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|ClinicalTrials.gov Identifier: NCT03335059|
Recruitment Status : Terminated (poor enrollment)
First Posted : November 7, 2017
Last Update Posted : April 15, 2020
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)|
|Actual Enrollment :||5 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|
|Actual Study Start Date :||April 4, 2019|
|Actual Primary Completion Date :||February 26, 2020|
|Actual Study Completion Date :||February 26, 2020|
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.
Patients experiencing a new occurrence of a benign tumor or low-grade Ta will be allowed to continue in the study (tumor will be resected); such an occurrence will not constitute an event in the primary analysis.
Patients with tumors of the ostium and/or upper tract and/or prostatic urethra will be considered to have achieved a complete response in the primary analysis but will be removed from the study.
- 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
|United States, Maryland|
|Chesapeake Urology Research Associates|
|Hanover, Maryland, United States, 21076|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Michael A O'Donnell, MD||University of Iowa|