مطالعه ي اثر درماني و عوارض شيمي- راديوتراپي هم زمان با سيس پلاتين هفتگي با يا بدون سلكوكسيب در كارسينوم نازوفارنكس: يك كارآزمايي باليني فاز3

The comparison between effect of chemoradiation with weekly cisplatin with or without celecoxib in treatment of nasopharyngeal carcinoma: A phase III clinical trial

ntroduction: Concurrent cisplatin-based chemoradiation is currently considered the treatment of choice for locoregional nasopharyngeal carcinoma. Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor which can potentially enhance the effect of radiotherapy. The aim of this study was to determine the efficacy and safety of celecoxib in nasopharyngeal carcinoma. Materials and Methods: Patients with newly diagnosed locoregional nasopharyngeal carcinoma were included in this clinical trial study. The patients were assigned to receive 7 weeks concurrent chemoradiation with weekly cisplatin and either celecoxib 100 mg twice daily or placebo. After completion of chemoradiation, all patients received combined chemotherapy with cisplatin plus 5-Fu every 3 weeks for 3 cycles. Clinical response rates and treatment-related toxicity were the primary and secondary end-point of the study. Results: Total of 50 eligible patients with the median age of 43 years were enrolled in the trial. Overall (complete and partial) clinical response rate was 100% in both groups. Complete and partial clinical response rates were 64% and 36% in study group and 44% and 56% in control group respectively (j^O.25). There was no difference in terms of treatment-related toxicity rates between two groups. Conclusions: This clinical trial showed that addition of celecoxib 100 mg twice daily to concurrent chemoradiation does not increase the response rates and treatment-related toxicities in patients with locoregional nasopharyngeal carcinoma.