Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck

Stereotactic Body Radiation Therapy (SBRT) is a relatively new radiation technique in which a
few very high doses of radiation are delivered to small, well-defined tumors. It has been
used effectively in other cancers like lung and liver. The goal is to deliver a radiation
dose that is high enough to kill the cancer while limiting radiation to surrounding healthy
organs. The daily dose of radiation is 2-3 times greater than conventional radiotherapy, but
it is given for only 5 days over a 2 week period. Conventional radiotherapy is given over 6-7
weeks. The chemotherapy drug, cisplatin is used as a radiation sensitizer and will be given
before each of the 5 radiation treatments.

Inclusion Criteria:

- Recurrence of previously pathologically proven squamous cell carcinoma of the head and
neck, including original primary sites in the paranasal sinuses, nasal cavity,
nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, and/or
involvement of cervical lymph nodes

- Prior radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥ 6 months prior to
enrollment

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

- Life expectancy > 6 months

- Medically unfit for surgery or deemed surgically unresectable by head and neck (H&N)
surgeon within 60 days prior to enrollment, or patient refusal of surgery

- Normal organ and marrow function

- No prior evidence of Grade 3 or greater toxicity or neuropathy

- Medically fit to receive cisplatin

Exclusion Criteria:

- Positive urine pregnancy test and/or breastfeeding. Women of childbearing potential or
sexually active males must be willing to use effective contraception throughout their
participation in the treatment phase of the study.

- Evidence of distant metastases

- Tumor size > 7 cm in one direction

- Tumor within 1 cm of the spinal cord

- Cardiac history: class III or greater congestive heart failure (CHF) or myocardial
infarction (MI) within last 6 months

- Medical condition or social situation that at the discretion of the principal
investigator (PI) would preclude them from completion of the trial