A Phase 1 interventional study of radiation in Squamous Cell Carcinoma of the Larynx, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by University of Texas Southwestern Medical Center · Phase 1, Interventional, and Treatment
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 15 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Severe, active co-morbidity, defined as follows:
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.
Radiation: radiation
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.
Also known as: HYpofractionateD RadioAblative
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 study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Squamous Cell Carcinoma of Head and Neck→
University of Texas Southwestern Medical Center