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

Feasibility of chemotherapy and regional hyperthermia in patients with intermediate /high risk non-muscle invasive transitional cell carcinoma of the bladder - A pilot study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24485

Enrollment

Registered

2010-09-29

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermediate risk/high risk non-muscle invasive bladder carcinoma intermediate/hoge risico niet-spier invasief blaascarcinoom

Interventions

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 tempe

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Feasibility en toxicity.	—

Secondary

Measure	Time frame
To develop a new bladder catheter with sufficient thermocouples to measure accurately the temperature on the bladder wall.	—

Contacts

Public ContactE.D. Geijsen

Postbus 22660

e.d.geijsen@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)