Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly
assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent
chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm).
Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy,
Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation
is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at
54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on
day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the
radiotherapy. The primary end point is response rates after radiotherapy, failure-free
survival (FFS) and toxic effects and treatment compliance. Secondary end points include
overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free
survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population;
the safety population include only patients who receive their randomly assigned treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
China: Ethics Committee