Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer

Conditions
-----------------
Recurrent Head and Neck Carcinoma

Intervention / Treatment
-----------------
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery. History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume. Estimated life expectancy > 12 weeks. Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2). Maximum tumor, or tumor bed, diameter < 5 cm. If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment. Ability to understand and willingness to sign a written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (SBRT)<br>Patients undergo stereotactic body radiation therapy with either standard radiation treatment software or HyperArc software technology for 2-3 fractions per week over a 2-week period for 5 fractions. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Radiation: Stereotactic Body Radiation Therapy<br>* Undergo SBRT<br>* Other names: Stereotactic Ablative Body Radiation Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | The time between the first dose of SBRT and death, assessed up to 2 years | 
| Progression-free survival (PFS) | The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented. | 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. | 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. | 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. | 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. | 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. | 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 |