Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT02110992
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
7 participants
INTERVENTIONAL
2014-04-30
2017-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Docetaxel + Stereotactic Radiation
Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by \> 48 hours.
Docetaxel
Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
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.
Interventions
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Docetaxel
Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Defined area of recurrence on imaging
* Previous head and neck radiation (RT) to \>/= 50 Gy
* Performance status score 0-1
* Time interval from previous RT \>/= 9 months
* Volume of disease appropriate for protocol treatment
* Minimum estimated survival of \>/= 3 months
* Age \>/= 18
* Adequate labs
Exclusion Criteria
* Original pathology report and radiation therapy records not available
* Prior spinal cord dose \> 45 Gy
* Surgery or chemotherapy within 4 weeks
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
18 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Brad Huth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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UCCI-HN-13-001
Identifier Type: -
Identifier Source: org_study_id
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