This phase II trial studies how well stereotactic body radiation therapy with HyperArc software technology works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. To evaluate local control and toxicity of patients who receive escalated dose stereotactic body radiation therapy (SBRT) reirradiation with HyperArc for recurrent head and neck cancer (rHNC). SECONDARY OBJECTIVES: I. To evaluate the clinical benefit of HyperArc through the analysis of overall survival (OS), progression-free survival (PFS) and locoregional progression-free survival (LPFS). EXPLORATORY OBJECTIVES: I. To evaluate dosimetric data including dose to target and organs at risk (OAR). OUTLINE: Patients undergo treatment planning with both standard radiation treatment software and HyperArc software technology. The most optimal plan will be delivered to a total dose of 55 Gy in 5 fractions, given 2-3 times weekly. After completion of study treatment, patients are followed up periodically for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Local control rate of the treated tumor target per Response Evaluation Criteria in Solid Tumors version 1.1, magnetic resonance imaging (MRI) response or positron emission tomography (PET) response
Will calculate the percentage and construct 95% exact confidence interval for local control rate.
Time frame: At 1 year
Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0
Data will be tabulated and summarized. Incidence of adverse events (AEs) will be summarized overall and with separate summaries for serious adverse events (SAEs), AEs leading to discontinuation, AEs leading to death, etc. The overall safety and tolerability will be assessed throughout the study period. All AE data will be listed individually by patient identifier.
Time frame: At 1 year
Overall survival (OS)
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
Time frame: The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
OS
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
Time frame: The time between the first dose of SBRT and death, assessed at 2 years
Median OS
The Kaplan-Meier method will be used to provide an estimate of median OS. The corresponding 95% confidence interval will also be presented.
Time frame: The time between the first dose of SBRT and death, assessed up to 2 years
Progression-free survival (PFS)
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The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
Time frame: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year
PFS
The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
Time frame: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years
Median PFS
The Kaplan-Meier method will be used to provide an estimate of median PFS. The corresponding 95% confidence interval will also be presented.
Time frame: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed up to 2 years
Locoregional progression-free survival (LPFS)
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
Time frame: From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 1 year
LPFS
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
Time frame: From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 2 years
Median LPFS
The Kaplan-Meier method will be used to provide an estimate of median LPFS. The corresponding 95% confidence interval will also be presented.
Time frame: From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed up to 2 years