The efficacy of an antigenic marker lesion for the therapeutic effect in patients with multiple, Ta/T1, G1/G2, non-muscle invasive bladder cancer (NMIBC) treated with TUR followed by IL-2 instillatio
Phase 3
Completed
- Conditions
- non-muscle invasive bladder carcinomabladder cancer1003836410004994
- Registration Number
- NL-OMON41468
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
Patients with the diagnosis multiple (< 10) resectable Ta(G1,2) or T1(G1,2) non-muscle invasive bladder carcinoma as diagnosed by pathological examination
Exclusion Criteria
Excluded are patients with CIS, or a cancer type other than urothelial cell carcinoma, or with a second malignancy (except treated basal cell carcinoma of the skin), or a tumour in the prostatic urethra or in a diverticulum or in the upper urinary tract
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Tumour-free period after treatment<br /><br>2. Percentage tumour-free patients 2 years after intervention<br /><br>3. Percentage complete regressions of marker tumours 3 months after<br /><br>intervention</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Values of different immunological parameters (e.g. T-cel populations and<br /><br>cytokine concentrations in the blood)<br /><br>2. Quality of life after the intervention</p><br>