Objectives: A prospective randomized trial was performed to compare concurrent chemoradiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC) in endemic regions of China.Methods: 115 patients with pathologically comfirmed nasopharyngeal low differentiated squamous cell carcinoma with≥T3 stage and (or)≥N2 stage according to 92 FuZhou staging system were randomly allocated into CCRT group (59 patients)and RT group(56 patients), similar dose and fractionation of radiotherapy was administered in both groups, CCRT group received Cisplatin 20 mg/m~2 twice a week during 1~7 weeks of radiotherapy. The locoregional recurrence rates, the progression-free survival (PFS) rates and overall survival (OS) rates were compared.Results: Complete response rate of the CCRT group and RT group three months after treatment were 88.1%(52/59) and 71.4%(40/56) respectively, there were significant difference statistically between the two groups(P<0.05).After a median follow-up 44 months, the locoregional recurrence rate of the CCRT group and RT were 8.5%(5/59) and 23.2%(13/56) respectively , there were significant difference statistically between the two groups(P=0.030). The 1, 3 and 5 year PSF rate was 81.4%,65.5%,65.5% and 78.6%,66.1%,66.1%,respectively( P= 0.931). The 1,3 and 5 year OS rate was 81.4%,75.8%,72.2% and 78.6%,70.9%,70.9%,respectively(P=0.774).The PFS and OS were not significant different statistically between the two groups.Conclusion: Although the complete response rate and the locoregional recurrence rate were significantly different in favor of CCRT group, In patients with locoregionally advanced NPC in endemic regions of China, low dose cisplatin used twice a week concurrent chemoradiotherapy cannot improve the PFS rate, and OS rate. Further study is needed to confirm this effect.
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