RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)
|ClinicalTrials.gov Identifier: NCT02471495|
Recruitment Status : Withdrawn
First Posted : June 15, 2015
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: Synergo® RITE + MMC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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 With Mitomycin C in Non-Muscle Invasive Bladder Cancer Patients With BCG-refractory CIS|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Synergo® RITE + MMC
Patients will receive 8 weekly treatments of Synergo® RITE + MMC, using the Synergo® System. Each treatment lasts about 60 minutes and consists of two 30-minute cycles with 40 mg MMC/50 ml sterile water for injection each cycle. These 8 treatments will be followed by a pause (see Table 1), after which a follow-up cystoscopy (first follow-up control) will be conducted during Weeks 12-13 (from the first treatment).
Patients will receive one Synergo® RITE + MMC treatment every 6 weeks. Each treatment lasts about 60 minutes and consists of two 30-minute cycles with 40 mg MMC/50 ml sterile water for injection each cycle. Maintenance treatments will be given until the end of 12 months after the patient's first induction treatment.
Device: Synergo® RITE + MMC
Synergo® system delivers homogenous microwave hyperthermia to the bladder wall in combination with bladder instillation of cold chemotherapeutic agent - Mitomycin C (MMC).The energy-delivering unit and the intravesical irrigation system are computer-controlled, The irrigation system consists of a disposable tubing line and catheter set. The catheter is a triple-lumen, silicone, transurethral Foley-type catheter.
MMC is constituted as a powder (40 mg) dissolved in 50 ml sterile water for injection.
- Recurrence-free survival [ Time Frame: 12 months ]The study will be deemed successful if the recurrence-free survival probability after 12 months is at least 30%.
- Complete Response Rate (CRR) [ Time Frame: 6 months after first treatment ]A satisfactory outcome will be if the CRR at 6 months is at least 40%.
- Rate of serious adverse events [ Time Frame: 12 months ]
- Proportion of patients who discontinue treatment for safety reasons. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471495
|Study Director:||Igal Ruvinsky, PhD||Medical Enterprises|
|Principal Investigator:||Shariat Shahrokh, Prof. med||Medical University Vienna, General Hospital|