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

Inclusion 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
• •o Note: A CT scan of the Neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools.
• •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.