No registrations found.
ID
Source
Brief title
Health condition
Bladder cancer, locally advanced disease, node positive disease, chemotherapy, lymph node dissection, chemoradiation
Sponsors and support
Postbus 90203, 1006 BE, Amsterdam
The Netherlands
Intervention
Outcome measures
Primary outcome
- Bladder-preservation rate
- No evidence of disease at 12 months followup
Secondary outcome
- 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
Background summary
Systemic treatment with cisplatin-based combination chemotherapy has been shown to improve the outcome of patients presenting with locally advanced muscle-invasive bladder cancer and patients with lymph node positive disease, albeit at best an absolute 6.5% increase in overall survival at 5-years follow-up[1-6]. Aims of the present study are: to evaluate the bladder preservation rate after chemoradiation, and furthermore assessment of the toxicity and complications of induction cisplatin-based combination chemotherapy followed by pelvic lymph node dissection (ePLND) and chemoradiation.
Study objective
After chemoradiation the bladder-preservation rate after two years followup will be around 85%
Study design
Quality of Life assessment will be performed using validated questionnaires: EuroQol EQ-5D-3L and SF-12. These questionnaires will be submitted at the following moments: T0 (entry of study); T6 (after 6 months); T12 (after 12 months); T24 (after 24 months).
Intervention
-Neoadjuvant chemotherapy
-Pelvic lymph node dissection
-Chemoradiation
R.P. Meijer
Utrecht
The Netherlands
rmeijer6@umcutrecht.nl/ r.meijer@nki.nl
R.P. Meijer
Utrecht
The Netherlands
rmeijer6@umcutrecht.nl/ r.meijer@nki.nl
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
-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
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 | NL5247 |
| NTR-old | NTR5504 |
| Other | NL51464.031.15 : M15CRB |