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The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
Sponsor: Sun Yat-sen University
Summary
The purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).
Official title: A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy with Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients with Locoregionally Advanced Nasopharyngeal Carcinoma
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2015-06
Completion Date
2025-04
Last Updated
2024-12-03
Healthy Volunteers
No
Conditions
Interventions
Gemcitabine
Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
cisplatin
Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
cisplatin
Active Comparator arm: Patients receive weekly cisplatin 40 mg/m² up to 7cycles during IMRT.
Intensity-modulated Radiotherapy
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China