Clinical Trial: HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer

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

Detailed Summary: 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.
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: toxicities [ Time Frame: 90 days ]

Number of participants with acute related serious adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • adverse events [ Time Frame: 2 years ]
    Number of participants with adverse events
  • quality of life [ Time Frame: 5 years ]
    Scale of quality of life questionnaire
  • disease control [ Time Frame: 5 years ]
    Number of participants with disease control (no evidence of disease, progression)
  • dosimetric improvement [ Time Frame: 2 weeks ]
    Scores of radiation quality review


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: May 7, 2015
Date Started: April 2015
Date Completion: December 2020
Last Updated: December 28, 2016
Last Verified: December 2016