Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

PRIMARY OBJECTIVES:

I. To evaluate local control and toxicity of patients who receive escalated dose stereotactic
body radiation therapy (SBRT) reirradiation with HyperArc for recurrent head and neck cancer
(rHNC).

SECONDARY OBJECTIVES:

I. To evaluate the clinical benefit of HyperArc through the analysis of overall survival
(OS), progression-free survival (PFS) and locoregional progression-free survival (LPFS).

EXPLORATORY OBJECTIVES:

I. To evaluate dosimetric data including dose to target and organs at risk (OAR).

OUTLINE:

Patients undergo treatment planning with both standard radiation treatment software and
HyperArc software technology. The most optimal plan will be delivered to a total dose of 55
Gy in 5 fractions, given 2-3 times weekly.

After completion of study treatment, patients are followed up periodically for 1 year.

Inclusion Criteria:

- Histologically confirmed recurrent head and neck cancer; either unresectable or status
post salvage surgery.

- History of radiation therapy for head and neck cancer with minimum 50% overlap of the
50% isodose line from prior treatment to the proposed treatment volume.

- Estimated life expectancy > 12 weeks.

- Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2).

- Maximum tumor, or tumor bed, diameter < 5 cm.

- If a woman is of childbearing potential, a negative serum pregnancy test must be
documented. Women of childbearing potential must agree to use adequate contraception
(hormonal or barrier method of birth control; or abstinence) for duration of study
participation and for up to 4 weeks following the study treatment.

- Ability to understand and willingness to sign a written informed consent.