Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
Conditions
Head and Neck Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel Type: Drug
Name: Stereotactic Radiation Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Status: Recruiting
Contact: UC Cancer Institute Clinical Trials Office - 513-584-7698 - kastla@ucmail.uc.edu
Start Date
April 2014
Completion Date
December 2019
Sponsors
University of Cincinnati
Source
University of Cincinnati
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page