Onderzoek naar de uitkomst van chemotherapie gevolgd door een lymfeklieroperatie en een gecombineerde behandeling van chemotherapie met uitwendige bestraling voor hoog-risico spier-ingroeiend blaaskanker (CHEMORAD-TRIAL)
- Conditions
- Bladder cancer, locally advanced disease, node positive disease, chemotherapy, lymph node dissection, chemoradiation
- Registration Number
- NL-OMON27865
- Lead Sponsor
- The Netherlands Cancer Institute-Antoni van Leeuwenhoek HospitalPostbus 90203, 1006 BE, AmsterdamThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Signed written informed consent
-Locally advanced urothelial carcinoma of the bladder (cT3-T4) or any cT-stage with cytologically or histologically proven node positive urothelial carcinoma (or positive FDG/PET-CT-scan with suspect lymph nodes, including supraregional retroperitoneal lymph nodes below the diaphragm.
Exclusion Criteria
-Distant metastases (M+)
-Severe bladder symptoms (necessitating cystectomy).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Bladder-preservation rate<br /><br>- No evidence of disease at 12 months followup<br>
- Secondary Outcome Measures
Name Time Method - Recurrence rates (local and distant)<br /><br>- Toxicity rates following induction chemotherapy<br /><br>- Complication rates following ePLND<br /><br>- Toxicity rates following chemoradiation<br /><br>- Quality of Life (EuroQol EQ-5D-3L; SF-12)<br /><br>- Disease specific survival<br /><br>- Recurrence free survival<br /><br>- Genetic biomarkers <br>