Intravesical Thermochemotherapy With Mitomycin-c

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Intravesical Mitomycin-C With Bladder Wall Hyperthermia in Intermediate and High Risk Non-muscle Invasive Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: bladder wall thermotherapy with Mitomycin-c


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed or followed as recurrent intermediate-risk non muscle invasive non muscle invasive bladder cancer according to the criteria of European Association of Urology. newly diagnosed or followed as recurrent high-risk non muscle invasive non muscle invasive bladder cancer according to the criteria of European Association of Urology. pathology of urothelial carcinoma Exclusion Criteria: Low bladder capacity (<150ml) increased post voiding residual urine (>150ml) untreatable or uncontrollable urinary tract infection history of urethral stricture presence of bladder diverticula larger than 1 cm pathology other than urothelial carcinoma WHO (World Health Organization) performance status > 2 upper urinary tract urothelial carcinoma diagnosis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: single group of patients composed of intermediate and high risk non muscle invasive bladder cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder wall thermochemotherapy<br>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<br>* application of intravesical mitomycin-C with hyperthermia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | recurrence rate of non muscle invasive bladder cancer during or after treatment | 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) | From the beginning of thermochemoterapy until the date of first documented progression assessed up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | side effects detected during TCT instillation | From the beginning of thermochemoterapy until the date of first documented side effect(s) assessed up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder, Thermochemotherapy, cancer