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Intravesical Docetaxel After Nephroureterectomy for UUT-UC
NCT03209206Phase 2
Key facts
- Status
- Unknown
- Start
- Jun 2017
- Primary completion
- Jun 2020
- Countries
- 1
- Sponsor
- Seoul National University Hospital
- Modality
- Small Molecules
- Drugs
- docetaxel
- Conditions
- upper urinary tract urothelial carcinoma (UTUC)
01
Overview
Phase 2, randomised, double-blind trial in upper urinary tract urothelial carcinoma (UTUC) comparing Docetaxel with Placebo (2 arms). Primary endpoint: Recurrence in bladder at 2 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Docetaxel
Single intravesical instillation of Docetaxel (75 mg in 100 cc saline)
Placebo
Single intravesical instillation of Normal Saline (100 cc)
03
Who it enrols
Patients with upper urinary tract urothelial carcinoma undergoing nephroureterectomy, with adequate bone marrow, hepatic, and renal function. Excludes patients with concomitant bladder tumor, recent bladder cancer, neurogenic bladder, or recent chemotherapy.
04
Endpoints
Primary
Recurrence in bladder
Secondary
Incidence of Treatment-Emergent Adverse Events
Overall Survival
Time to recurrence
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