Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck
- 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
- 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.
- 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
- Pregnant and nursing women are excluded because of the potential teratogenic effects
and potential unknown effects on nursing newborns.
- Previous treatment with cetuximab.