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Completed

NCT Number: NCT03694535

Intravesical Thermochemotherapy With Mitomycin-c

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bladder wall thermotherapy with Mitomycin-c

Drug

application of intravesical mitomycin-C with hyperthermia

Primary outcomes

  1. Recurrence

    Time frame: From the beginning of thermochemoterapy until the date of first documented recurrence assessed up to 2 years

    recurrence rate of non muscle invasive bladder cancer during or after treatment

  2. Progression rate

    Time frame: From the beginning of thermochemoterapy until the date of first documented progression assessed up to 2 years

    progression rate of non muscle invasive bladder cancer during or after treatment ( progress to muscle invasive stage or carcinoma in situ)

Secondary outcomes

  1. Side effects

    Time frame: From the beginning of thermochemoterapy until the date of first documented side effect(s) assessed up to 2 years

    side effects detected during TCT instillation

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Oct 3, 2018
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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