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

University of Cincinnati

Status and phase: Terminated; Phase 1

Conditions: Head and Neck Cancer

Treatments: Radiation: Stereotactic Radiation; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02110992

UCCI-HN-13-001

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

7 participants in 1 patient group

Docetaxel + Stereotactic Radiation

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Radiation: Stereotactic Radiation