Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

OBJECTIVES:

- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery
as boost therapy after standard chemoradiotherapy in patients with locally advanced head
and neck cancer.

- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery
as salvage therapy in patients with locally recurrent head and neck cancer.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after
prior standard therapy. Patients with residual disease after standard therapy are assigned to
group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned to
group 2.

All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning
CyberKnife® stereotactic radiosurgery (SRS) treatment.

- Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy
(2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.

- Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage
therapy (5 fractions) 3 times weekly.

After completion of study treatment, patients are followed periodically for up to 2 years.

Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Biopsy-confirmed* invasive head and neck cancer, including the following primary
sites:

- Nasopharynx

- Oropharynx

- Paranasal sinus

- Oral cavity

- Orbit

- Salivary gland NOTE: *Biopsy must be performed prior to initiation of external
beam radiotherapy (EBRT)

- Stage T2-4 tumor at the time of diagnosis

- Primary tumor ≤ 5 cm in diameter at the time of CyberKnife® stereotactic
radiosurgery (SRS)

- Meets one of the following criteria:

- Eligible for CyberKnife® SRS as boost therapy, as defined by one of the following
criteria:

- Planning to undergo definitive EBRT, with or without chemotherapy, with
curative intent for primary head and neck cancer

- Biopsy-confirmed locally persistent disease < 3 months after completion of
definitive EBRT

- Eligible for CyberKnife® SRS as salvage therapy*, as defined by one of the
following criteria:

- Biopsy-confirmed locally recurrent disease occurring ≥ 6 months after the
completion of radiotherapy; achieved a complete response to initial therapy
by imaging or clinical examination; had > 50% of the tumor volume in the
prior irradiated volume; and received > 45 Gy of radiotherapy

- Biopsy-confirmed locally recurrent disease occurring between 6 weeks and 6
months after the completion of radiotherapy; achieved a complete response to
initial therapy by imaging or clinical examination; had < 50% of the tumor
volume in the prior irradiated volume; and received > 45 Gy of radiotherapy
NOTE: *Not a candidate for salvage surgery or brachytherapy

- Anticipated total dose of radiotherapy to the spinal cord ≤ 50 Gy (including prior
dose)

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to achieve normal tissue tolerance to critical structures with the CyberKnife®
planning system

- Able to undergo CT simulation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Exclusion Criteria:

- No laryngeal or hypopharyngeal cancer

- No evidence of distant metastases

- No prior brachytherapy

- No prior CyberKnife® SRS boost or salvage therapy

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

- No active connective tissue disorders (e.g., lupus or scleroderma)