Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma

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.