drugset / Trial / NCT02969083
Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma
Phase 2
Unknown
200 enrolled
The European Uro-Oncology Group
Centre for Human Drug Research, Netherlands · collab
RandomizedParallel-groupOpen-labelOther
Summary
The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC) treatments based in real world data in various European countries. The study will allow to gain insight in the true proportion of patients that fit to receive complete cisplatin-based neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients with poor prognostic factors (PS and renal function) who receive only standard treatment (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic and treatment protocol.
Timeline
- Start
- 2018-05-28
- Primary completion
- 2024-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 30 mg/m2 | — |
| Subject | Vinblastine | Small molecule | 3 mg/m2 | — |