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RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471495
Recruitment Status : Withdrawn
First Posted : June 15, 2015
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medical Enterprises Europe B.V.

Brief Summary:
This multicenter, prospective, single-arm, phase 3 study will assess the proportion of disease-free patients, starting from administration of the first study treatment to at least 12-months after the first treatment, and up to 2 years (the latter only in patients choosing to participate in longer-term disease-free-survival data collection).

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: Synergo® RITE + MMC Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Synergo® RITE + MMC

Induction

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).

Maintenance

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.





Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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%.

  2. Rate of serious adverse events [ Time Frame: 12 months ]
  3. Proportion of patients who discontinue treatment for safety reasons. [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with CIS, with or without coexisting papillary NMIBC, who either:

    • fail to achieve a disease-free status by 6 months after initial BCG therapy, with maintenance or re-induction at 3 months due to either persistent or rapidly recurrent disease, or
    • experience a worsening in NMIBC state following initial BCG therapy presenting with a new NMIBC instance, other than TaLG.
  2. All clinical, intra-operative and pathological items for the EAU risk stratification must be documented including a bladder map.
  3. Patients with papillary disease must have undergone a repeat TUR:

    • if the initial TUR was incomplete.
    • if there was no muscle in the specimen after the initial TUR (except in TaLG tumors).
    • in all T1 tumors. TUR of T1 sites must include muscle.
    • in all HG tumors > 3cm.
  4. CT-IVU or IVU confirmation of absence of tumor(s) in the upper tract, kidney and ureters performed within 6 months before the treatment initiation in selected cases as recommended in latest EAU guidelines published prior to screening. If IVU protocol not available or contrast allergy/poor renal function preclude such imaging, then non-contrast CT or MRI of the abdomen/pelvis within the same timeframe will suffice.
  5. Visual inspection to exclude urothelial carcinoma (UC) in the urethra during cystoscopy.
  6. Biopsy of the prostatic urethra in male patients prior to recruitment to exclude UC of the prostatic urethra, in patients with:

    • tumor of trigone,
    • tumor of bladder neck, or
    • abnormal prostatic urethra
  7. All patients must have urine cytology collected from either voided urine or bladder wash within the screening period prior to recruitment.
  8. All patients must have prostatic urethral biopsies collected within the screening period prior to recruitment.
  9. Age ≥ 18 yrs.
  10. Normal kidneys and ureters.
  11. Pre-treatment hematology and biochemistry values within the limits:

    • Hemoglobin ≥ 10 g/dl
    • Platelets ≥ 150 x 10^9/L
    • WBC ≥ 3.0 x 10^9/L
    • ANC ≥ 1.5 x 10^9/L
    • Serum creatinine < 1.5 x ULN
    • SGOT < 1.5 x ULN
    • SGPT < 1.5 x ULN
    • Alkaline phosphatase < 1.5 x ULN
  12. Negative pregnancy test for women of childbearing potential.
  13. A life expectancy at least of the duration of the study (up to 13 months).
  14. Patients unfit or unwilling to have a full or partial (if appropriate) cystectomy.
  15. Signed informed consent.

Exclusion Criteria:

  1. Non-UC tumor of the urinary tract.
  2. Upper tract and intramural tumors (e.g., in ostium).
  3. Positive selective cytology from the upper tract.
  4. History of stage > T1 UC.
  5. Papillary tumor in repeat TUR in patients diagnosed with HG > 3cm and/or T1 in the initial TUR.
  6. Papillary tumor ≥ T1 in repeat TUR
  7. Known or suspected reduced bladder capacity. Patients will have a US estimation of maximum bladder capacity or void spontaneously the maximum they can retain in their bladder, and this will be used to determine urine volume. A minimum volume of 250 ml is required.
  8. Bleeding disorder.
  9. Macrohematuria of ≥ 250 RBC/uL or equivalent (e.g., > "+++" erythrocytes in a dipstick analysis) within 4 weeks before treatment start.
  10. Lactating women.
  11. Women of childbearing potential unwilling or unable to use adequate contraception if sexually active.
  12. More than a maintenance dose of oral corticosteroids (maintenance dose is defined as the same dose regimen over the past 6 months for a condition requiring continual corticosteroid treatment) or patients with an immunocompromised state for any reason.
  13. More than low-dose methotrexate (>17.5 mg once a week).
  14. Other malignancy within the past 5 years, except: non-melanomatous skin cancer cured by excision, surgically treated carcinoma in situ of the cervix or ductal CIS (DCIS)/lobular CIS (LCIS) of the breast or stable prostate cancer (under active surveillance or hormone control) with a life expectancy of more than 5 years.
  15. Any known allergy (e.g., to MMC) or adverse event that would prevent a prospective study participant from receiving the study treatment.
  16. Known untreated urethral strictural disease or bladder neck contracture or any other condition that may prevent catheterization with 21F catheter. Patients may undergo dilation or urethral incision before entering the study.
  17. Bladder diverticula with cumulative diameter > 1cm or tumor in a diverticulum.
  18. UTI at any time within 4 weeks before treatment start.
  19. Significant urinary incontinence (spontaneous, requiring use of pads).
  20. History of pelvic irradiation.
  21. Patients with implanted electronic devices (such as cardiac pacemakers) unless they receive permission from their treating physician (e.g., cardiologist) and are monitored by a treating physician during the treatment session.
  22. Participation in another study, unless discussed with and approved by the study manager.

Information from the National Library of Medicine

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): NCT02471495


Sponsors and Collaborators
Medical Enterprises Europe B.V.
Investigators
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Study Director: Igal Ruvinsky, PhD Medical Enterprises
Principal Investigator: Shariat Shahrokh, Prof. med Medical University Vienna, General Hospital
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Responsible Party: Medical Enterprises Europe B.V.
ClinicalTrials.gov Identifier: NCT02471495    
Other Study ID Numbers: RITE-2
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medical Enterprises Europe B.V.:
NMIBC
Non-Muscle-Invasive Bladder Cancer
Nonmuscle Invasive Bladder Cancer
BCG refractory
BCG failure
Carcinoma in situ
CIS
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases