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Lotingsstudie bij oppervlakkige blaaskanker met blaasspoelingen met of zonder warmtebehandeling


- candidate number23972
- NTR NumberNTR5751
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-feb-2016
- Secondary IDsNL 40086.018.12 EudraCTnummer
- Public TitleLotingsstudie bij oppervlakkige blaaskanker met blaasspoelingen met of zonder warmtebehandeling
- Scientific TitleA Phase III randomised trial of intravesical chemotherapy vs. chemohyperthermia in intermediate risk non-muscle invasive bladder cancer
- ACRONYMCHIB study
- hypothesislocoregional 70 MHz hyperthermia in combination with intravesical chemotherapy will improve recurrence free survival in comparison with intravesical chemotherapy alone in intermediate risk non muscle invasive bladder carcinoma
- Healt Condition(s) or Problem(s) studiedBladder carinoma, implant technical complications
- Inclusion criteriaPatients 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
Life expectancy of more than 2 years
Written informed consent
Minimum age of eightteen years
- Exclusion criteriaIntravesical MMC during the last 6 months
Bladder tumours other than urothelial carcinoma
Known allergy to MMC
Previous treatment with Bacillus Calmette Guérin
Small bladder volume less than 100 cc
Residual urine more than 200 cc measured by ultrasound
A history of muscle invasive urothelial carcinoma of the bladder
Urinary incontinence
Untreatable urine tract infection
Hip prosthesis
Pacemaker/ICD
Incapability of inserting catheters for thermometry or measuring temperatures in bladder or anal canal
Inability to comply with the treatment protocol
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-sep-2020
- Target number of participants212
- InterventionsThe intervention will be:
Arm 1 (standard arm): Following a complete resection of the bladder tumour(s): an induction period of 6 weekly courses with intravesical chemotherapy using Mitomycin C 40 mg followed by a maintenance scheme during 1 year of 1 instillation to be given at months 3, 6, 9 and 12.

Arm 2 (experimental arm): Following a complete resection of the bladder tumour(s): an induction period 6 weekly courses of intravesical chemotherapy using Mitomycin C 40 mg in combination with locoregional (70-90 MHz) microwave hyperthermia, followed by a maintenance scheme during 1 year of 1 instillation to be given at months 3, 6, 9 and 12.
- Primary outcomeTo describe the effect of additional treatment with loco-regional 70-90 MHz hyperthermia to the standard treatment with intravesical MMC on the recurrence rate in patients with an intermediate risk non-muscle invasive urothelial carcinoma of the bladder.
- Secondary outcomeTo describe the effect of the additional treatment with locoregional hyperthermia 70-90 MHz on tumour progression, acute toxicity, functional bladder capacity and quality of life. Study design: A Phase III randomised trial. Study population: Patients with intermediate risk non-muscle invasive urothelial
- Timepointsat 3,6,9,12, 2nd and 3rd year every six months TURT, Cystoscopy, Urinanalysis, Uroflowmetry, Residual urine volume determination, Upper urine tract imaging, Voiding diary, QoL EORTC QLQ-C30, QoL EORTC BSL24, Toxicity score (CTC 4.0) will be measured.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. E.D. Geijsen
- CONTACT for SCIENTIFIC QUERIESDrs. E.D. Geijsen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsA 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.

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.

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
- Brief summaryIn treatment of intermediate risk non-muscle invasive bladder cancer local recurrence rate remains high even after intravesical chemotherapy. The efficacy of a locoregional 70 MHz hyperthermia will be investigated in this study in combination with intravesical chemotherapy.
- Main changes (audit trail)
- RECORD15-feb-2016 - 22-mei-2016


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