Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Patients must have a pathologically confirmed recurrence (reappearance of previously
cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous
cell primary. Patients may have experienced more than one recurrence as long as the
first recurrence occurred ≥6 months following the end of the prior RT.

- The recurrence or second primary must be confined to the head and neck above the
clavicles (loco-regional recurrence).

- The majority (≥75%) of the tumor volume must have been in areas previously irradiated
to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.

- Patients must be at least 6 months from prior radiation therapy.

- If a resection is performed after the diagnosis of recurrence and before enrollment,
either microscopic or macroscopic disease must be present (i.e. positive margins or
gross residual).

- Karnofsky Performance Status 60-100.

- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤
1.5 mg/dl, within 6 weeks prior to registration.

- Must be able to submit previous radiation records (simulation and portal film if
available) in order to assure that cord tolerance is not exceeded.

- Patients must sign a study-specific informed consent form prior to study entry.

- The patient must be between the ages of 18 and 75.

Exclusion Criteria:

- Distant metastases.

- Completely resected recurrence with negative margins.

- Other concurrent invasive malignancies.

- Prior invasive malignancy unless disease free for at least two years (prior in situ
malignancies are permissible).

- Intercurrent medical illnesses which would impair patient tolerance to therapy or
limit survival.

- Pregnant and nursing women are excluded because of the potential teratogenic effects
and potential unknown effects on nursing newborns.

- Previous treatment with cetuximab.