RADIATION THERAPY &COMCOMITANT C225 IN HEAD/NECK SCC

University Of Wisconsin Madison, Madison WI

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Linked publications & trials

Abstract

This is a Phase III open-label, stratified, randomized study of radiation therapy alone versus radiotherapy concomitant with C225 therapy in patients with advanced squamous cell head and neck carcinoma. A total of 300 patients will be enrolled and the study will last approximate two years. Patients will be randomized using Pocock's minimization technique for balance. The primary objective of the study is to compare locoregional disease control, i.e., objective tumor response maintained for one year. The secondary objectives are: (1) to compare acute and late toxicity, (2) to compare disease-free survival and overall survival, (3) to compare quality of life, and (4) to correlate tumor EGFr expression level with clinical response.