This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objectives of this study are to: 1) determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC; 2) assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens; 3) define the acute and late toxicity of each treatment regimen; 4) evaluate whether there are differences in patient's QOL, perception of side effects and and performance status between treatment arms; and 5) establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation. Approximately 480 males and females age 18 years or older will take part in this study. Patients will be randomized to one of two study arms. Patients in arm 1 will receive radiation once daily, Monday through Friday, for seven weeks, as well as Cisplatin IV on days 1, 22, and 43 or radiotherapy. Patients in arm 2 will receive radiation once daily, Monday through Friday, for 3.5 weeks then twice a day, Monday through Friday, for 2.5 weeks. Cisplatin will also be administered on days 1 and 22 of radiotherapy. Follow-up will be conducted at 4 weeks, 3 months, 6 months, 12 months, then every 3 months for 1 year, every six months for 3 years and then annually for life. These visits will include physical examination/history, tumor assessment if clinically indicated, CT/MRI of tumor if indicated, and completion of 'Quality of Life' forms annually for years 2-5.
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