A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

• DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma (including variants, such as verrucous carcinoma, spindle cell carcinoma, or carcinoma not otherwise specified) of the head and neck, including the following subtypes:

• Oral cavity

• Oropharynx

• Larynx

• Clinical stage T1, N1-2, M0 OR T2-4a, N0-2, M0 disease based on the following diagnostic workup within the past 8 weeks:

• General history and physical examination by a Radiation Oncologist and/or Medical Oncologist

• Chest x-ray or chest CT scan (with or without contrast) or chest CT/PET scan (with or without contrast)

• Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for intermediate risk of recurrence:

• Perineural invasion

• Lymphovascular invasion

• Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) (no extracapsular extension)

• Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible)

• Pathologically confirmed T3 or T4a primary tumor

• T2 oral cavity cancer with > 5 mm depth of invasion

• No positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery

• PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

• Total bilirubin < 2 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN

• Serum creatinine < 2 times ULN OR creatinine clearance ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other invasive malignancy within the past 3 years, except for nonmelanomatous skin cancer or previously treated carcinoma in situ of the breast, oral cavity, or cervix

• No simultaneous primary or bilateral tumors

• No severe, active co-morbidity, including any of the following:

• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months

• Transmural myocardial infarction within the past 6 months

• Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy

• Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to have required oxygen therapy within the past year

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

• AIDS based on current Centers for Disease Control (CDC) definition

• Grade 3-4 electrolyte abnormalities according to CTCAE, v. 4, including any of the following:

• Serum calcium (ionized or adjusted for albumin) < 7 mg/dL or > 12.5 mg/dL*

• Glucose < 40 mg/dL or > 250 mg/dL

• Magnesium < 0.9 mg/dL or > 3 mg/dL*

• Potassium < 3.0 mmol/L or > 6 mmol/L*

• Sodium < 130 mmol/L or > 155 mmol/L* NOTE: *Despite intervention to normalize levels.

• No prior allergic reaction to cetuximab

• PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for this cancer

• Prior chemotherapy or anti-EGF therapy for a different cancer allowed

• No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields

• No concurrent amifostine as a radioprotector

• No concurrent granulocyte colony-stimulating factor or erythropoietin