Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2014
End Date:December 2019
Contact:UC Cancer Institute Clinical Trials Office
Email:kastla@ucmail.uc.edu
Phone:513-584-7698

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

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.


Inclusion Criteria:

- Recurrent or second primary squamous cell head and neck cancer

- 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:

- Primary tumors of the salivary gland

- 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
We found this trial at
1
site
University of Cincinnati Cancer Institute
Cincinnati, Ohio 45267
Principal Investigator: Michelle Mierzwa, MD
Phone: 513-584-7698
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mi
from
Cincinnati, OH
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