Head and Neck Cancer Clinical Trial
Official title:
A Phase I Study of Hypofractionated Preoperative Radiation for Head and Neck Cancers (HyPR-HN)
This is a phase 1 study to determine the safety of a condensed preoperative radiation regimen (10, 7, or 5 fractions) for the management of head and neck squamous cell carcinoma.
All subjects in this study will receive hypofractionated adjuvant radiation therapy, which will be subject to fractionation reduction, that being 10 fractions, 7 fractions, or 5 fractions, as compared to 30 fractions of conventional radiation therapy. The subjects will receive smaller number of fractions (total visits) but with a higher dose of radiation. Participants will receive a total radiation dose of 46 Gy in 10 fractions (Dose Level 1), 40 Gy in 7 fractions (Dose Level 2), or 35 Gy in 5 fractions (Dose Level 3), depending on the assigned experimental total fractions. Radiation will be delivered using intensity modulated radiation therapy (IMRT) with a daily cone-beam CT for five days a week, for less than two weeks depending on the assigned dose level at the time of enrollment. ;
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