No registrations found.
ID
Source
Brief title
Health condition
blaaskanker, spierinvasief
bladder cancer, muscle invasive
Sponsors and support
KWF
Intervention
Outcome measures
Primary outcome
Disease free survival
Secondary outcome
toxicity
costs
bladder preservation rate
Qol
Background summary
A bladder sparing treatment with radiochemotherapy or brachytherapy in patients with non-metastasised muscle invasive bladder carcinoma leads to comparable disease free survival and overall survival rates compared to radical cystectomy in non-randomised comparative retrospective studies. In over 70% of patients the bladder and its function can be preserved with bladder sparing treatments. However, a radical cystectomy is still considered as standard treatment by the lack of randomized controlled trials. It is very unlikely that such a trial will be conducted. Prospective matched control studies are second best in the comparison of outcome between both treatment. It is likely that medical costs, toxicity and quality of life will be better in the sparing approach arm, but again not previously prospectively analyzed.
Study objective
A bladder sparing approach results in comparable disease free survival, overall survival with less toxicity, less costs and a high functional bladder preservation rate compared to a radical cystectomy.
Study design
DFS at 2 and 5 years
Intervention
NA
Meibergdreef 9
M.C.C.M. Hulshof
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664231
m.c.hulshof@amc.nl
Meibergdreef 9
M.C.C.M. Hulshof
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664231
m.c.hulshof@amc.nl
Inclusion criteria
muscle invasive urothelial cell carcinoma of the bladder
T2-4aN0M0
curative intend
Exclusion criteria
No previous RT
multifocal disease
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 |
---|---|
NTR-new | NL7159 |
NTR-old | NTR7358 |
Other | ZonMW project. : 843004124 |