muscle invasive bladder cancer muscle invasive bladder carcinoma
Conditions
Interventions
In all patients, CTCs will be enumerated. If no CTCs are detected, the patient
will proceed to undergo local radical treatment (radical cystectomy) and will
not receive neoadjuvant chemotherapy. In
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histopathologically confirmed muscle-invasive urothelial carcinoma of the bladder. - Clinical stage T2-T4a N0-N1 bladder cancer. - Candidate for radical local treatment consisting of radical cystectomy. - Age * 18 years. - Signed informed consent
Exclusion criteria
Exclusion criteria: - Muscle-invasive bladder cancer other than urothelial carcinoma (adenocarcinoma, squamous cell carcinoma, small cell carcinoma, neuro-endocrine tumor). - History of other malignant disease with a tumor-free interval of * 5 years. - Known or suspected coincidental prostate cancer. - Metastatic disease at staging, as assessed by a CT-scan of thorax and abdomen - Local or systemic adjuvant treatment after radical cystectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study will be the 2-year overall survival rate in nonmetastatic MIBC patients without detectable CTCs treated with radical local treatment without prior neoadjuvant chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include 2-year overall survival in the remaining patients and cancer-specific survival, relapse-free survival, local relapse-free survival and metastasis-free survival for all the patients. In addition, the expression pattern of the 20-gene panel is also a secondary endpoint. | — |
Countries
Netherlands
Outcome results
None listed