A randomized, multicenter phase III clinical trial comparing gemcitabine and cisplatin with 5-fluorouracil and cisplatin in the treatment of recurrent or metastatic nasopharyngeal carcinoma.

TPS6098 Background: Nasopharyngeal carcinoma (NPC) is highly sensitive to both radiotherapy and chemotherapy. Nowadays, the regimen of 5-Fluorouracil plus cisplatin (FP) is widely used in recurrent or metastatic (R/M) NPC patients, but the response period is usually short and the adverse reaction is frequent and badly tolerant. Several small phase II trials suggest gemcitabine plus cisplatin (GP) has promising efficacy and better tolerability. Unfortunately, there is no head to head comparison study to evaluate these two regiments in this setting. This phase III trial will evaluate the efficacy and safety of GP versus FP as first-line therapy in patients with R/M NPC. Methods: The population consists of R/M NPC patients that failed the radical radiotherapy or chemotherapy-naive advanced NPC (stage IV). Eligible patients will be randomized in a 1:1 ratio to receive either GP (gemcitabine 1,000 mg/m2 on days 1, 8, cisplatin 80 mg/m2 on day 1, every 3 weeks) or FP regimens (5-Fluorouracil 4,000 mg/m2 CIV ove...