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Gemcitabine Maintenance in N3 NPC
NCT03403829Phase 3
Key facts
- Status
- Unknown
- Start
- Jan 2018
- Primary completion
- Dec 2020
- Countries
- 1
- Sponsor
- Fudan University
- Modality
- Small Molecules
- Drugs
- gemcitabine
- Conditions
- nasopharyngeal carcinoma (NPC)
01
Overview
Phase 3, randomised, open-label trial of gemcitabine in nasopharyngeal carcinoma (NPC) (2 arms), sponsored by Fudan University. Primary endpoint: Distant Metastatic Free Survival at 5 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Gemcitabine Maintenance Arm
Standard CCRT followed by Gemcitabine maintenance
Control Arm
Standard CCRT followed by observation
03
Who it enrols
Patients with AJCC/UICC 8th edition N3 nasopharyngeal carcinoma, WHO type II or III pathology, age 18-60, and KPS >= 70. Patients with prior anti-tumor treatment, WHO type I pathology, pregnancy, or other malignant tumors are excluded.
04
Endpoints
Primary
Distant Metastatic Free Survival
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