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PULS-Pal: Personalized Radiotherapy for Head and Neck Cancer

This study, called PULS-Pal, is testing a new way to give radiation therapy for head and neck cancer. It uses a personalized treatment called PULSAR along with HyperArc© technology. This approach delivers radiation in a few larger doses, adjusting to changes in your body during treatment. Researchers want to see if this method can control tumors better with the same or fewer side effects than standard treatments. You might be able to join if you are 18 or older and have head and neck cancer (primary, recurrent, localized, or metastatic) and cannot receive or choose not to have standard treatments. The main goal is to measure how long it takes for the treated tumor to grow again, up to one year after treatment. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 43 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo CT scans for radiation planning, and potentially PET and MRI scans. You would receive radiation therapy to the head and neck tumor site every 14 days.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow up to measure the time until the treated tumor grows again, for up to one year from the start of the study.

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NCT06572423

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

Recruiting
NAAges 18+InterventionalSupportive care
Jonsson Comprehensive Cancer Center
~43 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Personalized ultrafractionated stereotactic adaptive radiotherapyVolume Modulated Arc TherapyComputed TomographyPositron Emission TomographyMagnetic Resonance ImagingBest Practice

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to progression of the treated tumor target
Measured over From baseline up to 1 year

Conditions

Head and Neck Carcinoma
Localized Head and Neck Carcinoma
Metastatic Head and Neck Carcinoma
Recurrent Head and Neck Carcinoma

Explore related trials

Malignant Head and Neck Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Travis Courtney, MD · PRINCIPAL_INVESTIGATOR · University of California at Los Angeles

Who to contact

Mili Santoso
[email protected]
310 267-2153
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\>= 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

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

What this trial measures

  • Time to progression of the treated tumor targetFrom 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.