a study of decreasing radiation therapy and chemotherapy in people with head and neck cancer

Conditions: Head and Neck Cancer; Head and Neck Carcinoma; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. the study will look at how effective the treatment approach is against participants' cancer.


Eligibility criteria:
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. exclusion criteria: * 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 o note: exceptions can be made for patients with simultaneous primaries outside the h\&n if determined by the pi/co-pi that the patient can proceed with protocol activities. * 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.

Keywords: unknown primary squamous cell carcinoma head and neck cancer head and neck squamous cell carcinoma fluoromisonidazole 18f-fmiso memorial sloan kettering cancer center 22-227