Bladder cancer, locally advanced disease, node positive disease, chemotherapy, lymph node dissection, chemoradiation
Conditions
Interventions
-Neoadjuvant chemotherapy
-Pelvic lymph node dissection
-Chemoradiation
Sponsors
The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
Postbus 90203, 1006 BE, Amsterdam
The Netherlands
Eligibility
Inclusion criteria
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. -Renal function: Creatinin clearance ¡Ý 50 mL/min (calculated) and serum creatinin ¡Ü1.5 x UNL. -Karnofsky performance 70
Exclusion criteria
Exclusion criteria: -Distant metastases (M+) -Severe bladder symptoms (necessitating cystectomy). -Bilateral hydronefrosis. -Persisting hydronephrosis after induction chemotherapy (necessitating cystectomy). A temporary nefrostomy is indicated during chemotherapy. -Previous radiation therapy on pelvic region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Bladder-preservation rate - No evidence of disease at 12 months followup | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recurrence rates (local and distant) - Toxicity rates following induction chemotherapy - Complication rates following ePLND - Toxicity rates following chemoradiation - Quality of Life (EuroQol EQ-5D-3L; SF-12) - Disease specific survival - Recurrence free survival - Genetic biomarkers | — |
Contacts
Public ContactR.P. Meijer
Department of Urology UMC Utrecht
Outcome results
None listed