A phase III study of late course accelerated hyperfractionated radiotherapy versus conventionally fractionated radiotherapy in patients with nasopharyngeal carcinoma.

Objective: To compare the efficacy and toxicity of late course accelerated hyperfractionated radiotherapy (LCAF) with conventionally fractionated (CF) radiotherapy in the treatment of nasopharyngeal carcinoma (NPC). Methods: Between March 1998 and November 2002, 200 eligible patients with NPC were randomized to receive either LCAF (48 Gy in 40 fractions, 2 fractions per day, 1.2 Gy/fraction, with an interval of >= 6 h, 5 d/wk, followed by 30 Gy in 20 fractions using 2 fractions per day, 1.5 Gy/fraction, 5 d/wk) or CF (35 fractions, 2.0 Gy/fraction/d, 5 d/wk, to a total dose of 70 Gy). Results: All patients completed the treatment. Overall baseline characteristics of the study population of the 2 arms were well balanced. With a median follow-up of 6.9 years, the 5-year local control rate was higher in the LCAF arm (87.6% vs. 75.9%, P = 0.044). The 5-year overall survival rates were 74.1% vs. 58.0% (P = 0.024) for the LCAF arm and the CF arm, respectively. LCAF patients had a higher occurrence of acute mucositis and a more evident weight loss than CF patients, whereas incidence rates of radiation-induced damage to the central nervous system were similar in the 2 arms. Conclusions: LCAF achieved higher local control and overall survival rates than CF radiotherapy, without increasing radiation-related late complications such as cranial nerve palsy.