The addition of regionale hyperthermia to treatment with intravesical chemotherapy with mitomycin C is feasible and not toxic.
ID
Bron
Verkorte titel
Aandoening
intermediate risk/high risk non-muscle invasive bladder carcinoma
intermediate/hoge risico niet-spier invasief blaascarcinoom
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility en toxicity.
Achtergrond van het onderzoek
Feasibility of treatment with regional hyperthermia with 70 MHz and intravesical chemotherapy in intermediate/high risk non-muscle invasive bladder carcinoma.
The Netherlands.
Doel van het onderzoek
The addition of regionale hyperthermia to treatment with intravesical chemotherapy with mitomycin C is feasible and not toxic.
Onderzoeksopzet
Wk 1-6, wk 12, wk 24, wk 36, wk 48.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2429 |
| NTR-old | NTR2538 |
| Ander register | MEC AMC : 08/196 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |