An interventional study of Personalized ultrafractionated stereotactic adaptive radiotherapy and Volume Modulated Arc Therapy in Head and Neck Carcinoma, Localized Head and Neck Carcinoma and Metastatic Head and Neck Carcinoma, sponsored by Jonsson Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck cancer (HNC) who are ineligible for or decline standard of care treatment. Researchers want to evaluate if using HyperArc and PULSAR together will deliver higher, possibly more effective doses, resulting in better tumor control with the same or fewer side effects than smaller routine doses. PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment. HyperArc radiation treatment planning technology is a tool that allows for target dose escalation to tumor tissue while maintaining minimal head and neck organs-at-risk doses compared to other radiation treatment planning software. Undergoing PULSAR and HyperArc technology together may be a safe and effective palliative treatment option for patients with HNC.
A significant proportion of patients with de novo or recurrent head and neck cancer are not candidates for standard-of-care definitive treatment(s), including standard-of-care stereotactic body radiation therapy (SBRT). Current palliative radiation therapy regimens result in adequate symptom improvement though with suboptimal local control and/or toxicity. The durability of symptom and local control in these patients is becoming more important as advances in systemic therapy are improving these patients' survival.
After confirmation of eligibility, enrolled patients will undergo radiation simulation and planning per standard of care. HyperArc technology will be used for treatment planning given prior internal validation of its superiority. Dosimetric constraints will be adapted from the available literature as appropriate. Patients will receive an 11 Gray fraction of radiation to the head and neck tumor site every 14 +/-10 days.
It is possible that patients will experience anatomical and/or tumor changes during the radiation therapy course such that patient alignment for radiation therapy is no longer optimized to the original CT simulation and radiation plan. In such cases where it is determined that adaptive planning is needed, the Investigators will abort planned radiation therapy and immediately perform re-simulation and re-planning if the anatomic change is significant enough to put adjacent normal tissue at significant risk; otherwise, the Investigators will re-plan with the next fraction of radiation to minimize treatment delays. This will be determined by the treating physician through standard of care clinical criteria and procedures.
The frequency of re-simulation and adaptive planning as well as associated changes in dosimetry will be measured. Patients will receive 5 PULSAR fractions for a total radiation dose of 55 Gray. Treatment will be terminated early in cases of intolerable treatment-related toxicity, altered clinical context, or the patient declines further treatment.
Enrolled patients are permitted to receive systemic therapy at the discretion of their medical oncologist.
Patient follow-up will be measured from the time of receipt of first PULSAR fraction to 12 months after receipt of the last PULSAR fraction.
Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo standard of care CT simulation for radiation treatment planning using HyperArc software. 1 week later, patients undergo PULSAR fraction therapy once daily on days 0, 14, 28, 42, and 56. Patients may also undergo Positron Emission Tomography (PET) scan and MRI during follow-up.
Procedure: Personalized ultrafractionated stereotactic adaptive radiotherapy · Radiation: Volume Modulated Arc Therapy · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Procedure: Magnetic Resonance Imaging · Other: Best Practice · Behavioral: University of Washington Quality of Life Scale, Version 4 · Behavioral: Functional Assessment of Cancer Therapy-Head & Neck
PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment.
Also known as: PULSAR
Use HyperArc technology
Also known as: VMAT, Volumetric Modulated Arc Therapy
Undergo CT simulation for radiation planning
Also known as: CAT, CAT Scan, Computed Axial Tomography, CT, CT Scan
Undergo PET
Also known as: Medical Imaging, PET, PET Scan, proton magnetic resonance spectroscopic imaging
Undergo MRI
Also known as: Magnetic Resonance, MRI
Undergo standard of care
Also known as: standard of care
Complete questionnaire
Also known as: UW QOL v4
Complete questionnaire
Also known as: FACT Head and Neck Questionnaire, FACT-H&N Questionnaire
Time to progression of the treated tumor target
Progression of the treated tumor target will be determined clinically and/or radiographically as applicable. Time to progression of the treated tumor target will be reported descriptively for each patient. One-year treated tumor target progression free survival will be estimated by the Kaplan-Meier method, descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), and will consider the competing risk of death.
Time frame: From baseline up to 1 year
Grade 3 or higher treatment-related toxicity
According to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Will be performed across the whole cohort, as well as separate analysis stratifying patients by Human Papillomavirus/p16 status.
Time frame: Within 24 months after treatment completion
Disease progression free survival (PFS)
Disease progression of any type will be determined clinically and/or radiographically as applicable. Time to disease progression will be reported descriptively for each patient. One-year disease progression free survival will be estimated by the Kaplan-Meier method, descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), and will consider the competing risk of death.
Time frame: From enrollment to the first objectively documented disease progression, either in or out of the treated field per radiographic and/or clinical evaluation, or death due to any cause, assessed up to 24 months
Overall survival (OS)
The Kaplan-Meier method will be used to summarize overall survival.
Time frame: From enrollment until death due to any cause, assessed up to 24 months.
Longitudinal patient reported outcomes on the University of Washington Quality of Life (UW-QoL) Questionnaire
Represented by changes from baseline in the pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood, anxiety, intimacy, fear of cancer recurrence, overall health-related quality of life, and overall quality of life domains. Each domain ranges from 0-100 with higher scores meaning a better outcome. Changes will be analyzed with respect to whether they represent minimally important differences.
Time frame: From baseline up to 24 months
Longitudinal patient reported outcomes on the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Questionnaire
Represented by changes from baseline in the physical well-being, social/family well-being, emotional well-being, functional well-being domains and additional concerns. Each domain has multiple specific questions with a 5 point Likert-type scale for responses. Changes will be analyzed with respect to whether they represent minimally important differences.
Time frame: From baseline up to 24 months
Radiation therapy dosimetry
Will be performed on patients included in analysis sets FAS and EAS across the whole cohort, as well as separate analyses stratifying patients by Human Papillomavirus/p16 status.
Time frame: through study completion, on average of 24 months
Radiation therapy planning
Frequency of re-simulation and/or adaptive planning required with PULSAR
Time frame: through study completion, on average of 24 months
Incidence of adverse events (AE)
Safety analyses will be performed for patients included in analysis set Statistical Analysis Software (SAS)
Time frame: From baseline up to 24 months
Plan to share: No
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Jonsson Comprehensive Cancer Center