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

Completed
Conditions
intermediate risk/high risk non-muscle invasive bladder carcinomaintermediate/hoge risico niet-spier invasief blaascarcinoom
Registration Number
NL-OMON24485
Lead Sponsor
AMC
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
15
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;

Exclusion Criteria

1. Intravesical MMC during the last 12 months;

2. Bladder tumors other than transitional cel carcinoma;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Feasibility en toxicity.
Secondary Outcome Measures
NameTimeMethod
To develop a new bladder catheter with sufficient thermocouples to measure accurately the temperature on the bladder wall.<br>
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