An interventional study of bladder wall thermotherapy with Mitomycin-c in Bladder Cancer, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Prevention
To investigate effect of intravesical mitomycin-C(MMC) applied with bladder wall thermotherapy system on reccurrence and progression status of intermediate and high risk non muscle invasive bladder cancer
Before the application of TCT, complete transurethral bladder tumour resection (TURBT) was performed. RE-TURBT was conducted within 4 weeks for patients with initial T1 pathology. The first TCT instillation was applied at 1mo following the TURBT or the RE-TURBT.
Thermochemotherapy application and treatment schedule:
The bladder wall TCT (BWT) system (Elmedical Ltd, Hod-Hasharon, Israel) was used as a conductive heating modality. MMC (40 mg; MMC Kyowa Hakko Kogyo Co., Ltd., Tokyo, Japan) was mixed with 50 mL of 0.9% saline solution and applied using a disposable silicone 20Fr 3-way TCT catheter (UniThermia catheter; Elmedical Ltd). In each session, the bladder was irrigated with MMC solution at 42°C-45°C for 45 min via the BWT system. The treatment schedule consisted of an initial 6-week instillation, followed by control cystoscopy and urine cytology in the 3rd month and monthly instillations up to 1 yr. Urine cytology and cystoscopy were performed every three months. The samples were collected from the suspected areas during cystoscopy. At the end of the first year, control cystoscopy with random bladder biopsies was conducted. During the second year, routine controls were conducted every three months. Subsequently, follow-ups were performed every six months. In case of development of any complication in a patient, TCT was discontinued. Before each instillation of TCT, clear urine cultures were obtained from all patients. No prophylactic anticholinergic was administered prior to intravesical TCT. If TUR BT pathology was Ta or T1 during the follow-up, it was accepted as a recurrence. If it was CIS or T2, it was accepted as a progression. All adverse events observed during the study were recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [9. All study protocols were approved by the local ethical committee at our institution. An informed consent was obtained from all patients.
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This study's enrollment of 44 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
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Exclusion Criteria:
Mitomycin-C application with bladder wall thermochemotherapy system after TUR bladder tumor in intermediate and high risk non muscle invasive bladder cancer
Drug: bladder wall thermotherapy with Mitomycin-c
application of intravesical mitomycin-C with hyperthermia
Recurrence
recurrence rate of non muscle invasive bladder cancer during or after treatment
Time frame: From the beginning of thermochemoterapy until the date of first documented recurrence assessed up to 2 years
Progression rate
progression rate of non muscle invasive bladder cancer during or after treatment ( progress to muscle invasive stage or carcinoma in situ)
Time frame: From the beginning of thermochemoterapy until the date of first documented progression assessed up to 2 years
Side effects
side effects detected during TCT instillation
Time frame: From the beginning of thermochemoterapy until the date of first documented side effect(s) assessed up to 2 years
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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TC Erciyes University