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

Feasibility of chemotherapy and regional hyperthermia in patients with intermediate/high risk non-muscle invasive transitional cell carcinoma of the bladder - chemohyperthermia in non invasive bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32637
Enrollment
10
Registered
2008-09-26
Start date
2008-09-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

non invasive bladder cancer non invasive urothelial cell carcinoma of the bladder

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 tem

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with intermediate/ high risk Ta-1 grade 3 or Ta-1 grade 2 recurrent or carcinoma in situ (CIS) non-muscle invasive transitional cell carcinoma of the bladder.

Exclusion criteria

Exclusion criteria: *Intravesical (Mitomycin C) MMC during the last 12 months *Bladder tumors other than transitional cel carcinoma *Known allergy to MMC *Small bladder volume; less than 100 cc measured by uroflowmetry *Residual urine > 100 cc measured by ultrasound *A history of muscle invasive carcinoma of the bladder *Urinary incontinence *Hip prosthesis *Pacemaker

Design outcomes

Primary

MeasureTime frame
Toxicity will be measured using the Common Toxicity Criteria. With these criteria immunological symptoms, constitutional symptoms and renal/genitourinary symptoms can be categorized. If the treatment has to be delayed two times in a row because of toxicity, treatment will be discontinued

Secondary

MeasureTime frame
Satisfying thermometry with the new bladder catheter

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)