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Neoadjuvant Gemcitabine and Cisplatin for Upper Tract TCC
NCT00696007Phase 2
Key facts
- Status
- Withdrawn
- Start
- Apr 2008
- Primary completion
- Apr 2010
- Countries
- 1
- Sponsor
- Lahey Hospital & Medical Center
- Modality
- Small Molecules
- Drugs
- gemcitabinecisplatin
- Conditions
- upper tract urothelial carcinoma (UTUC)
01
Overview
Phase 2, open-label trial of gemcitabine and cisplatin in upper tract urothelial carcinoma (UTUC) (2 arms), sponsored by Lahey Hospital & Medical Center. Primary endpoint: Pathological Response to Neoadjuvant Chemotherapy at 5 years. Planned start Apr 2008; status: withdrawn.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Neoadjuvant Chemotherapy + Surgery
Gemcitabine and Cisplatin followed by Nephroureterectomy
Historical Control
Retrospective cohort of Nephroureterectomy alone
03
Endpoints
Primary
Pathological Response to Neoadjuvant Chemotherapy
Secondary
Overall Survival
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