Trials / Terminated
TerminatedNCT02464137
HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer
A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-04-27
- Primary completion
- 2019-03-04
- Completion
- 2019-03-04
- First posted
- 2015-06-08
- Last updated
- 2020-08-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02464137. Inclusion in this directory is not an endorsement.