Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
NCT03114462 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2026-04-15
Summary
To find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The safety of this radiation will also be studied.
Conditions
- Malignant Neoplasms of Respiratory and Intrathoracic Organs
- Squamous Cell Carcinoma of the Larynx
Interventions
- RADIATION
-
Stereotactic Hypofractionated Radioablation
Starting dose is 8.0 Gy per fraction for 5 fractions (total dose = 40.0 Gy). Subsequent cohorts of participants receive an additional 0.5 Gy per fraction.
- BEHAVIORAL
-
Questionnaires
Quality of life and symptom questionnaires completed at: Baseline, on days receiving HYDRA, 6 weeks after last dose of HYDRA, 3 months after last dose of HYDRA, and 6 months after last dose of HYDRA. Also after the 6 month follow-up visit, every 3 months for the first 2 years, and then every 6 months after that for up to 5 years.
Sponsors & Collaborators
-
Cancer Prevention Research Institute of Texas
collaborator OTHER -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Jack Phan, MD, PHD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-09
- Primary Completion
- 2027-06-01
- Completion
- 2027-06-01
Countries
- United States
Study Locations
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