Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are
randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in
both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with
intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.27 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. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and
cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is
failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional
failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic
effects. All efficacy analyses are conducted in the intention-to-treat population, and the
safety population include only patients who receive their randomly assigned treatment.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
Jun Ma, M.D.
Sun Yat-sen University
China: Ethics Committee