A Study of Decreasing Radiation Therapy and Chemotherapy in People with Head and Neck Cancer

Eligibility Criteria

• * Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity/paranasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies).
• * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and/or co-PI approval)
• * If the primary site is oropharynx or unknown primary, P16 IHC must be negative.
• * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible.
• * Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET/CT.
• * 18 years of age or older.
• * Must not have received prior radiation therapy or chemotherapy for HNC.
• * Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study.
• * Karnofsky Performance Status (KPS) ≥ 70.
• * CT or MRI of the Neck with and without contrast
• * Adequate hematologic function within 30 days prior to registration, defined as follows:
• * White Blood Count (WBC) ≥ 2,000 cells/µL
• * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
• * Platelets ≥ 100,000 cells/mm3
• * Hemoglobin ≥ 8.0 g/dL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g/dL is acceptable
• * Adequate renal function within 30 days prior to registration, defined as follows:
• * Serum creatinine \< 1.5 mg/dL or creatinine clearance (CrCl) ≥ 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \[(140 - age) x (weight in kg)\] / \[(Serum Cr mg/dL) x (72)\] CrCl female = 0.85 x (CrCl male)
• * Patients with serum creatinine \> 1.5 mg/dL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman
• * Adequate hepatic function within 30 days prior to registration, defined as follows:
• * Bilirubin \< 2 mg/dL
• * AST or ALT \< 3 x the upper limit of normal
• * Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential.
• * The subject/legally authorized representative (LAR) must provide study-specific informed consent prior to study entry.
• * All nasopharyngeal, nasal cavity/paranasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.
• * Any T4 or N3 patients
• * Any prior radiotherapy to the head and neck region.
• * Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\&N cancer is permissible.
• * Prior chemotherapy or radiotherapy within the last three years.
• * Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes).
• * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%.
• * Subjects with simultaneous primary cancers outside of the oropharynx
• * Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding.
• * Severe, active co-morbidities defined as follows:
• * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
• * Transmural myocardial infarction within the last 6 months.
• * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.
• * Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects.