We like to demonstrate that treatment of non-muscle invasive bladder carcinoma with incomplete TUR and IL-2 is therapeutically more effective than treatment with complete TUR and IL-2.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Tumour-free period after treatment
2. Percentage tumour-free patients 2 years after intervention
3. Percentage complete regressions of marker tumours 3 months after
intervention
Secondary outcome
1. Values of different immunological parameters (e.g. T-cel populations and
cytokine concentrations in the blood)
2. Quality of life after the intervention
Background summary
Non-muscle-invasive carcinoma of the bladder is usually treated with Trans
Urethral Resection (TUR) followed by instillation of a chemotherapeuticum or an
immunotherapeuticum. The tumour recurs in 30 - 85 % of the patients; the median
tumour-free period is only about 5 months.
We have performed 2 phase II studies: incomplete TUR leaving a marker tumour of
ca 1 cm (Krakau) and a study with complete TUR (Vilnius). In both studies the
patients received IL-2 instillations after TUR. Patients treated with complete
TUR had a median disease-free period of 5 - 6 months, whereas in patients
treated with incomplete TUR the median disease-free survival was more than 24
months.
These results led to the hypothesis that incomplete TUR followed by IL-2
instillations caused significantly better therapeutic effects than complete TUR
followed y IL-2 instillations. This can be explained as a marker tumour
(incomplete TUR) contains antigens that initiate the anti-tumour immune
reaction; this initial immune reaction is, subsequently, stimulated by
instilled IL-2
Study objective
We like to demonstrate that treatment of non-muscle invasive bladder carcinoma
with incomplete TUR and IL-2 is therapeutically more effective than treatment
with complete TUR and IL-2.
Study design
This is a randomised open clinical intervention study of 2 years. There are 2
groups: a test group treated with incomplete TUR and a control group treated
with complete TUR
Intervention
Incomplete TUR, leaving a marker tumour that stimulates the therapeutic effect
of IL-2 instillations
Study burden and risks
The test patients receive the same interventions as the control patients.
If our hypothesis is correct, then the test group will get significantly less
recurrent bladder tumours than the control
group
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020397-42-NL |
| CCMO | NL32293.029.10 |