single-modality phase I dose escalation toxicity study for first-line curative treatment of head and neck squamous cell carcinoma.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients in each dose cohort will all be treated as a single group. The starting dose will be 8.5 Gy per fraction for 5 fractions (total dose = 42.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per fraction.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
toxicities
Number of participants with acute related serious adverse events
Time frame: 90 days
adverse events
Number of participants with adverse events
Time frame: 2 years
quality of life
Scale of quality of life questionnaire
Time frame: 5 years
disease control
Number of participants with disease control (no evidence of disease, progression)
Time frame: 5 years
dosimetric improvement
Scores of radiation quality review
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.