Clinical Trial Finder

Inclusion Criteria:

• - Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma Not Otherwise Specified (NOS), etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post-radiation complications.

• - Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.

• - General history and physical examination prior to registration; - Chest X-ray (at a minimum) or chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) prior to registration.

• - Total resection of the patient's cancer (i.e., no residual disease after total resection of the patient's cancer ).

• - One or more indications for postoperative radiotherapy, based upon pathologic findings: - Perineural invasion; - Lymphovascular invasion; - Single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular extension); - Close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin); - Pathologically confirmed T3 or T4a primary tumor; - T2 oral cavity cancer with ≥ 5 mm depth of invasion.

• - Zubrod Performance Status 0-1.

• - Age 18-75.

• - Negative pregnancy test within 14 days prior to registration for women of childbearing potential.

• - Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.

• - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial.

• - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

Exclusion Criteria:

• - Recurrence of the study cancer.

• - History of systemic lupus erythematosus or systemic sclerosis (scleroderma).

• - Pregnancy and individuals unwilling to discontinue nursing.

• - Feeding tube (gastric or jejuno) at the time of registration.

• - Anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy.

Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.

• - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed.

• - Per the operative and/or pathology report, 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; Note: 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.

PRIMARY OBJECTIVE:

• I. To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial.

SECONDARY OBJECTIVES:

• I. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion.

• II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications.

ARM I: Patients undergo surgery per standard of care followed by hypofractionated radiotherapy. Patients receive 50 Gy over 4 weeks (i.e., 2.5 Gy per day x 20 fractions). Radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer. Patients are followed up at 1 month, 3 months, 6 months and 12 months post H-PORT therapy.

Arms

Experimental: Hypofractionated Postoperative Radiotherapy (H-PORT)

H-PORT of 50 Gy given over 4 weeks.

Interventions

Radiation: - Hypofractionated Postoperative Radiotherapy

Hypofractionated Postoperative Radiation Therapy