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Background: Concurrent chemo radiation is the current standard of care in locally advanced head and neck cancer, but in our set-up, all patients cannot be admitted for chemotherapy or cannot tolerate chemo radiation, or do not want surgery and/or surgery is not possible. The present study was planned to compare the efficacy of concomitantly administered Gefitinib with radiation therapy and radiation alone in locally advanced oral cavity cancer that are not fit or able to tolerate concurrent chemotherapy. Material and Methods: This was a single center, nonstratified, single blind, nonplacebo-controlled, parallel group intervention study with imbalanced randomization performed at our institute. Adult patients aged 40-65 years, male or female, irrespective of epidermal growth factor receptor (EGFR) status, Karnofsky scale score more than 70, biopsy-proven SCC, locally advance oral cavity cancer, normal hematology parameters, renal function and liver function tests for normal before recruitment were enrolled in the study. Exclusion criteria were patients who were previously treated with either chemotherapy or radiotherapy (RT). Arm1 include only RT, whereas arm 2 includes Gefitinib with RT. Results: Sixty patients were included in the study, 30 in each arm. In Gefitinib plus RT arm, complete response was seen in 18 patients (60%), in only RT arm, complete response was seen in 10 patients (33.33%). There was no significant difference in acute toxicities and late toxicities. Conclusion: This study shows significant response to treatment and improvement in the Gefitinib plus RT as compared with RT alone. However, the findings of this study need to be confirmed by a study with a larger group of patients and a longer period of follow-up.
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