After chemoradiation the bladder-preservation rate after two years followup will be around 85%
ID
Bron
Verkorte titel
Aandoening
Bladder cancer, locally advanced disease, node positive disease, chemotherapy, lymph node dissection, chemoradiation
Ondersteuning
Postbus 90203, 1006 BE, Amsterdam
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Bladder-preservation rate<br>
- No evidence of disease at 12 months followup
Achtergrond van het onderzoek
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.
Doel van het onderzoek
After chemoradiation the bladder-preservation rate after two years followup will be around 85%
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
-Neoadjuvant chemotherapy
-Pelvic lymph node dissection
-Chemoradiation
Algemeen / deelnemers
R.P. Meijer
Utrecht
The Netherlands
rmeijer6@umcutrecht.nl/ r.meijer@nki.nl
Wetenschappers
R.P. Meijer
Utrecht
The Netherlands
rmeijer6@umcutrecht.nl/ r.meijer@nki.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5247 |
| NTR-old | NTR5504 |
| Ander register | NL51464.031.15 : M15CRB |