No registrations found.
ID
Source
Brief title
Health condition
intermediate risk/high risk non-muscle invasive bladder carcinoma
intermediate/hoge risico niet-spier invasief blaascarcinoom
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility en toxicity.
Secondary outcome
To develop a new bladder catheter with sufficient thermocouples to measure accurately the temperature on the bladder wall.
Background summary
Feasibility of treatment with regional hyperthermia with 70 MHz and intravesical chemotherapy in intermediate/high risk non-muscle invasive bladder carcinoma.
The Netherlands.
Study objective
The addition of regionale hyperthermia to treatment with intravesical chemotherapy with mitomycin C is feasible and not toxic.
Study design
Wk 1-6, wk 12, wk 24, wk 36, wk 48.
Intervention
The 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 41°C.
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.
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2429 |
| NTR-old | NTR2538 |
| Other | MEC AMC : 08/196 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |