Clinical trial NCT03694535: Intravesical Thermochemotherapy With Mitomycin-c
Official title: Intravesical Mitomycin-C With Bladder Wall Hyperthermia in Intermediate and High Risk Non-muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Thermochemotherapy
bladder
cancer
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group of patients composed of intermediate and high risk non muscle invasive bladder cancer
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence
timeFrame: From the beginning of thermochemoterapy until the date of first documented recurrence assessed up to 2 years
measure: Progression rate
timeFrame: From the beginning of thermochemoterapy until the date of first documented progression assessed up to 2 years
Secondary outcomes:
measure: Side effects
timeFrame: From the beginning of thermochemoterapy until the date of first documented side effect(s) assessed up to 2 years
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Department of Urology, Ercieys University, Faculty Of Medicine,
Study officials:
affiliation: TC Erciyes University Medical Faculty
name: Abdullah Demirtas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moskovitz B, Meyer G, Kravtzov A, Gross M, Kastin A, Biton K, Nativ O. Thermo-chemotherapy for intermediate or high-risk recurrent superficial bladder cancer patients. Ann Oncol. 2005 Apr;16(4):585-9. doi: 10.1093/annonc/mdi124. Epub 2005 Feb 25.
citation: Colombo R, Salonia A, Leib Z, Pavone-Macaluso M, Engelstein D. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). BJU Int. 2011 Mar;107(6):912-8. doi: 10.1111/j.1464-410X.2010.09654.x. Epub 2010 Oct 4.