Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
NCT02110992 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2019-11-25
Summary
The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.
Conditions
Interventions
- DRUG
-
Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
- RADIATION
-
Stereotactic Radiation
SBRT will be given over 5 fractions separated by \> 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.
Sponsors & Collaborators
-
University of Cincinnati
lead OTHER
Principal Investigators
-
Brad Huth, MD · University of Cincinnati
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2017-03-29
- Completion
- 2017-03-29
Countries
- United States
Study Locations
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