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Clinical Trial Summary

single-modality phase I dose escalation toxicity study for first-line curative treatment of head and neck squamous cell carcinoma.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02464137
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase Phase 1
Start date April 27, 2015
Completion date March 4, 2019

See also
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Active, not recruiting NCT03370276 - Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma Phase 1/Phase 2
Recruiting NCT03114462 - Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer Phase 1