A prospective evaluation of weekly versus 3 weekly cisplatin for adjuvant chemoradiotherapy in oral cavity cancer

In this study, the patients of oral cavity cancer due for adjuvant chemoradiotherapy(CRT), will be considered after applying suitable inclusion and exclusion criteria. Patients of both genders, age between 18 years to 65 years, ECOG 0-1 will be included having high risk features of margin positivity and/or extracapsular extension. Patient having prior history of malignancy, history of CRT or synchronous malignancies will be excluded. Patients will be randomized in two two arms by computer generated random number table. In one arm, along with radiation concurrent chemotherapy(CT) will be given weekly. In other arm, along with radiation, concurrent CT will be given 3 weekly. Patients will be given Cisplatin CT however patients having impaired hearing function tests, namely Pure Tone Audiometry (PTA)/ Impedance Audiometry (IA) will be given Carboplatin. In weekly arm, Cisplatin will be given at 40mg/sq. meter of body surface area weekly for 6 weeks and in 3 weekly arm, Cisplatin will be given at 100mg/sq. meter body surface area 3 weekly. For patients having impaired hearing function tests, in weekly arm Carboplatin will be given at (AUC)2 (Area Under Curve), while in 3 weekly arm Carboplatin will be given at (AUC)5. After that patients will be assessed to compare the locoregional control being the primary endpoint. And secondary end points being overall survival (OS), disease free survival (DFS), Acute toxicity, Late toxicity and Quality of Life assessment.