Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly
assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus
concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control
arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every
three weeks for three cycles during radiotherapy. Patients in the investigational arm
receive docetaxel(60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2
on Days 1 to 5) every three weeks for three cycles before the radiotherapy. Patients are
stratified according to the treatment centers and stage. The primary end point is
failure-free survival (FFS). Secondary end points include overall survival (OS), distant
failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response
rates after treatments and toxic effects. 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Failure-free survival is calculated from the date of randomisation 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