PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER<br>
- Conditions
- 'bladder cancer' and 'high-risk muscle invasive bladder cancer'100383641000499410038365
- Registration Number
- NL-OMON43780
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
All patients with locally advanced (T3-4) and/or node positive bladder cancer (>=N1), who are fit to receive cisplatin-based combination chemotherapy and who are eligible for surgery, may be included in this study. ;
- 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 >= 50 mL/min (calculated) and serum creatinin <=1.5 x UNL.
- In case of hydronefrosis: relative function of the hydronefrotic kidney should be at least 30%.
- Karnofsky performance >=70
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-To evaluate the bladder-preservation rate after chemoradiation<br /><br>-To evaluate the recurrence of disease after 12 months followup, following<br /><br>chemoradiation</p><br>
- Secondary Outcome Measures
Name Time Method <p>- 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 </p><br>