UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
NCT Number: NCT03892720
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90095, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Undergo SBRT
Other names: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Time frame: At 1 year
Will calculate the percentage and construct 95% exact confidence interval for local control rate.
Time frame: At 1 year
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: The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
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
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 up to 2 years
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: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year
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
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 up to 2 years
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 in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 1 year
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
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 up to 2 years
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: Up to 2 years
Data will be collected but not analyzed.
Time frame: Up to 2 years
Will perform correlation analysis to explore serum markers predictive of efficacy endpoints.
Jonsson Comprehensive Cancer Center
Other
A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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