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Brief Title: HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer
Official Title: A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer
Study ID: NCT02464137
Brief Summary: single-modality phase I dose escalation toxicity study for first-line curative treatment of head and neck squamous cell carcinoma.
Detailed Description: HYDRA will consist of 5 fraction SBRT treatment targeting only grossly evident disease localized by examination and standard diagnostic CT, MR, and PET-CT imaging. Prophylactic coverage of uninvolved at-risk mucosal and nodal drainage basins will be strictly disallowed. The initial dose cohort will be treated to a total of 42.5 Gy in five equal fractions delivered every other day over a two week period (biologically equivalent to 66 Gy delivered in 2 Gy daily fractions), drawn from our successful institutional experience with similar dosing and fractionation for early-stage larynx SBRT. Escalation of total dose will proceed in 2.5 Gy increments, up to a final target dose of 50 Gy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Name: Lucien Nedzi, MD
Affiliation: UTSW Medical Center
Role: PRINCIPAL_INVESTIGATOR