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

• Status: Terminated
• Trial end date: 2017-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Docetaxel

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