Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal) (PULS-Pal)

February 3, 2026 updated by: Jonsson Comprehensive Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California at Los Angeles
        • Contact:
        • Principal Investigator:
          • Travis Courtney, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >= 18 years old
  • Diagnosis of primary or recurrent, localized or metastatic (American Joint Committee on Cancer (AJCC) 8th Edition stages I-IV) head and neck cancer. In primary diagnosis cases, pathologic confirmation is required. In recurrent and/or metastatic diagnosis cases, pathologic confirmation is not required if not beneficial to the patient as standard of care, and diagnosis can be assumed based on clinical and/or radiographic evidence
  • Ineligible for or declines standard of care definitive treatment(s), which will be documented in the patient's trial screening progress note in their electronic medical record by the treating physician
  • Measurable disease within the head and/or neck clinically and/or on imaging studies (CT, PET, MRI) within 30 days from date of enrollment
  • Patient maximum tumor(s) or tumor bed diameter must be less than 10cm
  • In a woman of childbearing potential, a negative serum or urine pregnancy test within 1 week of treatment start 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
  • Patients with a tracheostomy and/or a percutaneous endoscopic gastrostomy tube are eligible for inclusion

Exclusion Criteria:

  • Pregnant or breast-feeding
  • More than 1 prior radiation treatment course directed to the treatment area over the patient's lifetime. In patients who have received 1 prior radiation treatment course directed to the treatment area, that prior radiation treatment course must have concluded at least 6 months prior to trial enrollment
  • Any comorbidity or condition which would limit full compliance with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (PULSAR and HyperArc)
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: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • PET
  • PET Scan
  • proton magnetic resonance spectroscopic imaging
  • Medical Imaging
Other: Best Practice
Undergo standard of care
Other Names:
  • standard of care
Procedure: Personalized ultrafractionated stereotactic adaptive radiotherapy
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.
Other Names:
  • PULSAR
Radiation: Volume Modulated Arc Therapy
Use HyperArc technology
Other Names:
  • VMAT
  • Volumetric Modulated Arc Therapy
Procedure: Computed Tomography
Undergo CT simulation for radiation planning
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • CT Scan
Behavioral: University of Washington Quality of Life Scale, Version 4
Complete questionnaire
Other Names:
  • UW QOL v4
Behavioral: Functional Assessment of Cancer Therapy-Head & Neck
Complete questionnaire
Other Names:
  • FACT Head and Neck Questionnaire
  • FACT-H&N Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression of the treated tumor target
Time Frame: From baseline up to 1 year
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.
From baseline up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3 or higher treatment-related toxicity
Time Frame: Within 24 months after treatment completion
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.
Within 24 months after treatment completion
Disease progression free survival (PFS)
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
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.
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)
Time Frame: From enrollment until death due to any cause, assessed up to 24 months.
The Kaplan-Meier method will be used to summarize overall survival.
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
Time Frame: From baseline up to 24 months
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.
From baseline up to 24 months
Longitudinal patient reported outcomes on the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Questionnaire
Time Frame: From baseline up to 24 months
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.
From baseline up to 24 months
Radiation therapy dosimetry
Time Frame: through study completion, on average of 24 months
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.
through study completion, on average of 24 months
Radiation therapy planning
Time Frame: through study completion, on average of 24 months
Frequency of re-simulation and/or adaptive planning required with PULSAR
through study completion, on average of 24 months
Incidence of adverse events (AE)
Time Frame: From baseline up to 24 months
Safety analyses will be performed for patients included in analysis set Statistical Analysis Software (SAS)
From baseline up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Travis Courtney, MD, University of California at Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Estimated)

December 16, 2028

Study Completion (Estimated)

December 16, 2029

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-000663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Head and Neck Carcinoma

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe