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Feasibiblity of treatment with heat in combination with intravescial chemotherapy in the treatment of non-muscle invasive bladder cancer.


- candidate number8507
- NTR NumberNTR2538
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2010
- Secondary IDs08/196 MEC AMC
- Public TitleFeasibiblity of treatment with heat in combination with intravescial chemotherapy in the treatment of non-muscle invasive bladder cancer.
- Scientific TitleFeasibility of chemotherapy and regional hyperthermia in patients with intermediate /high risk non-muscle invasive transitional cell carcinoma of the bladder - A pilot study.
- ACRONYMCHIB study
- hypothesisThe addition of regionale hyperthermia to treatment with intravesical chemotherapy with mitomycin C is feasible and not toxic.
- Healt Condition(s) or Problem(s) studiedIntermediate risk/high risk non-muscle invasive bladder carcinoma
- Inclusion criteria1. Patients with an intermediate or high risk non-muscle invasive transitional cell carcinoma of the bladder according to the EAU definition; Ta-1 grade 3 or Ta-1 grade 2 recurrent or Carcinoma in situ;
2. A complete transurethral resection has to be performed within 3-6 weeks prior to study treatment. Complete tumour eradication must be verified by taking biopsies from suspected areas. The treatment session should begin 3-8 weeks after the initial TURB;
3. WHO performance status of 0-2;
4. Life expectancy of more than 24 months;
5. Written informed consent.
- Exclusion criteria1. Intravesical MMC during the last 12 months;
2. Bladder tumors other than transitional cel carcinoma;
3. Known allergy to MMC;
4. Small bladder volume; less than 100 cc measured by uroflowmetry;
5. Residual urine > 100 cc measured by ultrasound;
6. A history of muscle invasive transitional cell carcinoma of the bladder;
7. Urinary incontinence;
8. Hip prosthesis;
9. Pacemaker.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate
- Target number of participants15
- InterventionsThe intervention consists of 6 weekly courses of intravesical chemotherapy with MMC, 40 mg. MMC will be concomitantly given with locoregional 70 MHz microwave hyperthermia, given for 1 hour at a temperature of at least 41C.
This induction phase will be followed by a maintenance period of 12 months during which 4 single courses of hyperthermia in combination with MMC will be given: At 3, 6, 9 and 12 months.
- Primary outcomeFeasibility en toxicity.
- Secondary outcomeTo develop a new bladder catheter with sufficient thermocouples to measure accurately the temperature on the bladder wall.
- TimepointsWk 1-6, wk 12, wk 24, wk 36, wk 48.
- Trial web siteN/A
- statusstopped: trial finished
- 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)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryFeasibility of treatment with regional hyperthermia with 70 MHz and intravesical chemotherapy in intermediate/high risk non-muscle invasive bladder carcinoma.
The Netherlands.
- Main changes (audit trail)
- RECORD29-sep-2010 - 2-jul-2015


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