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

Stopped early · Phase 1

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02110992

Run by

University of Cincinnati

People needed

7

Starts

2014-04-01

Expected to finish

2017-03-29

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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