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Concurrent Docetaxel and Cisplatin with IMRT in High-Risk NPC
NCT02610556Phase 2
Key facts
- Status
- Unknown
- Start
- Jan 2016
- Primary completion
- Jan 2020
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Small Molecules
- Drugs
- docetaxel
- Conditions
- nasopharyngeal carcinoma (NPC)
01
Overview
Phase 2, randomised, open-label trial of docetaxel in nasopharyngeal carcinoma (NPC) (2 arms), sponsored by Sun Yat-sen University. Primary endpoint: Overall Survival at 2 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
TP plus IMRT
Docetaxel 60 mg/m2 D1 + Cisplatin 25 mg/m2 D1-3 q3w x 3 cycles + IMRT
DDP plus IMRT
Cisplatin 100 mg/m2 D1 q3w x 3 cycles + IMRT
03
Who it enrols
Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, staged T1N3M0, T2-3N2-3M0 or T4N0-3M0, with pretreatment EBV DNA >= 1500 copies/mL and adequate organ function.
04
Endpoints
Primary
Overall Survival
Secondary
Failure-Free Survival
Distant Metastasis-Free Survival
Locoregional Relapse-Free Survival
Incidence of Grade 3 or Higher Acute Toxicities
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