A Phase II Trial of Moderate Hypofractionated Chemoradiation In Postoperative Cases of Carcinoma Oral Cavity

Abstract

Introduction: Conventional fractionation in post-operative adjuvant radiotherapy (usually 60 Gy in 2 Gy per fraction delivered over six weeks) remains the standard in carcinoma oral cavity. Post-operative hypofractionated radiotherapy is less explored especially in post-operative oral cavity cancers. The aim of this study is to evaluate postoperative moderate hypofractionation as the adjuvant treatment in post-operative oral cavity cancer.Method: Patients of oral cavity cancers meriting adjuvant postoperative irradiation were inducted in the study. Hypofractionation consisted of a total dose of 52 Gy in 20 fractions over 4 weeks with concurrent chemotherapy. The primary endpoint was acute toxicity and late toxicity according to CTCAE V4.03 classification. The secondary endpoints included progression free survival at 1 year. Acute toxicity within 3 months of treatment and late toxicity at 1year follow up.Result: Thirty patients were recruited over 18 months. All patients completed a minimum of 1 year of follow-up. Twenty-Nine patients completed planned radiotherapy doses within a median treatment time of 30 days (27)(28)(29)(30)(31)(32)(33). Grade 2, 3and 4 skin reactions were seen in 86.2%, 10.34%, and 3.4% respectively. Grade 2,3,4 mucositis was seen in 55.17%, 41.3%, 3.4% patients respectively during treatment (acute toxicity). Recurrence was seen in 17% of patients at 3 months. Progression free survival at 1 year was 51%. Overall survival in 1 year was 79%. Conclusion:The schedule of 52 Gy in 20 fractions with concomitant chemotherapy is tolerable in patients with better compliance and equivalent PFS to conventional fractionation postoperative radiotherapy. Phase 3 trial is required for further validation of results.