|- candidate number||23972|
|- NTR Number||NTR5751|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-feb-2016|
|- Secondary IDs||NL 40086.018.12 EudraCTnummer|
|- Public Title||Lotingsstudie bij oppervlakkige blaaskanker met blaasspoelingen met of zonder
|- Scientific Title||A Phase III randomised trial of intravesical chemotherapy vs. chemohyperthermia
in intermediate risk non-muscle invasive bladder cancer|
|- ACRONYM||CHIB study|
|- hypothesis||locoregional 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) studied||Bladder carinoma, implant technical complications|
|- 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|
Life expectancy of more than 2 years
Written informed consent
Minimum age of eightteen years
|- Exclusion criteria||Intravesical 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
Untreatable urine tract infection
Incapability of inserting catheters for thermometry or measuring temperatures in
bladder or anal canal
Inability to comply with the treatment protocol
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2015|
|- planned closingdate||1-sep-2020|
|- Target number of participants||212|
|- Interventions||The 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 outcome||To 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 outcome||To 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|
|- Timepoints||at 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|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.D. Geijsen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. E.D. Geijsen|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||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.
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 summary||In 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)|
|- RECORD||15-feb-2016 - 22-mei-2016|