A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy 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 concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational
arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical
radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the
investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1
to 5) every four weeks for three cycles after completion of radiotherapy. Patients are
stratified according to the treatment centers. The primary end point was failure-free
survival (FFS). Secondary end points included overall survival (OS), distant failure-free
survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates
after treatments, toxic effects and treatment compliance. All efficacy analyses were
conducted in the intention-to-treat population; the safety population included only patients
who received 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 randomization to the date of the first failure at any site.
Jun Ma, M.D.
Sun Yat-sen University
China: Ethics Committee