This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Hypofractionated Postoperative Radiation Therapy
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Dose-Limiting Toxicity (DLT)
All grades are based on Common Terminology Criteria for Adverse Events (CTCAE v.5). H-PORT in this population will be deemed safe if 0-2 patients out of the first 12 evaluable patients experience DLTs. Should 3 or more patients experience DLTs at any time point during the DLT evaluation period, then accrual to the trial will be stopped, if applicable. Once 12 evaluable eligible patients have completed their DLT assessment, the rate of unacceptable DLTs and 95% confidence interval will be summarized using proportions for binary outcomes and the exact binomial method.
Time frame: From the start of H-PORT up 12 months post-radiation
Incidence of Adverse Events
Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Counts and percentages will be provided for the worst grade AE experienced.
Time frame: From the start of H-PORT up to 12 months post-radiation
Rate of radiation interruptions
Counts and percentages will be provided for treatment interruptions.
Time frame: From the start to the end of H-PORT, assessed up to 4 weeks
Rate of radiation discontinuations
Counts and percentages will be provided for treatment discontinuations.
Time frame: From the start to the end of H-PORT, assessed up to 4 weeks
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