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otingsstudie bij oppervlakkige blaaskanker met blaasspoelingen met of zonderwarmtebehandeling

Recruiting
Conditions
intermediate risk non muscle invasive bladder cancer, Mitomycin C, intravesical chemotherapy, locoregional hyperthermia, chemohyperthermia, recurrence free survivalintermediair risico niet spier invasief blaas carcinoom, Mitomycine C, intravesicale chemotherapie, locoregionale hyperthermie, chemohyperthermie, recidief vrije survival
Registration Number
NL-OMON21384
Lead Sponsor
Academic Medical Center Amsterdam
Brief Summary

A Systematic Review of Regional Hyperthermia Therapy in Bladder Cancer. Thomas Andrew Longo, Ajay Gopalakrishna, Matvey Tsivian, Megan Van Noord, Coen R Rasch, Brant Inman, Debby Geijsen. International Journal of Hyperthermia. 2016 in press. <br><br> Combining Mitomycin C and Regional 70 MHz Hyperthermia in Patients with Nonmuscle Invasive Bladder Cancer: A Pilot Study. Geijsen ED, de Reijke TM, Koning CC, Zum Vörde Sive Vörding PJ, de la Rosette JJ, Rasch CR, van Os RM, Crezee J. J Urol. 2015 Nov;194(5):1202-8. <br><br> Novel multisensor probe for monitoring bladder temperature during locoregional chemohyperthermia for nonmuscle-invasive bladder cancer: technical feasibility study. Cordeiro ER, Geijsen DE, Zum Vörde Sive Vörding PJ, Schooneveldt G, Sijbrands J, Hulshof MC, de la Rosette J, de Reijke TM, Crezee H. J Endourol. 2013 Dec;27(12):1504-9

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
212
Inclusion Criteria

Patients with an intermediate risk non muscle invasive urothelial carcinoma of the bladder. For determination of the risk group the EAU scoring system will be used
performance status of 0 to 2

Exclusion Criteria

Intravesical MMC during the last 6 months

Bladder tumours other than urothelial carcinoma

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To describe the effect of additional treatment with loco-regional<br>70-90 MHz hyperthermia to the standard treatment with intravesical MMC<br>on the recurrence rate in patients with an intermediate risk non-muscle<br>invasive urothelial carcinoma of the bladder.<br>
Secondary Outcome Measures
NameTimeMethod
To describe the effect of the additional treatment with locoregional<br>hyperthermia 70-90 MHz on tumour progression, acute toxicity,<br>functional bladder capacity and quality of life.<br>Study design: A Phase III randomised trial.<br>Study population: Patients with intermediate risk non-muscle invasive urothelial
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