Recruiting

PULS-Pal

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06572423

Conditions

Head and Neck Carcinoma

Localized Head and Neck Carcinoma

Metastatic Head and Neck Carcinoma

Recurrent Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Personalized ultrafractionated stereotactic adaptive radiotherapy

Volume Modulated Arc Therapy

Computed Tomography

Positron Emission Tomography

Magnetic Resonance Imaging

Study Details

Brief summary:

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.

Conditions

Head and Neck Carcinoma

Localized Head and Neck Carcinoma

Metastatic Head and Neck Carcinoma

Recurrent Head and Neck Carcinoma

Study ID

NCT06572423

Start date

Oct 25, 2024

Status verified date

Feb, 2026

Completion date

Dec 16, 2029

Anticipated

Primary completion date

Dec 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

43 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Volume Modulated Arc Therapy

Use HyperArc technology

Computed Tomography

Undergo CT simulation for radiation planning

Positron Emission Tomography

Undergo PET

Magnetic Resonance Imaging

Undergo MRI

Best Practice

Undergo standard of care

University of Washington Quality of Life Scale, Version 4

Complete questionnaire

Functional Assessment of Cancer Therapy-Head & Neck

Complete questionnaire

Primary outcome measure

  • Time to progression of the treated tumor target [ Time Frame: From baseline up to 1 year ]

Central Contacts and Locations

Central contacts

Mili Santoso

310 267-2153msantoso@mednet.ucla.edu

Vincent Basehart

3102678954vbasehart@mednet.ucla.edu

Locations

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Mili Santoso

310-267-2153msantoso@mednet.ucla.edu

Vincent Basehart

3102678954vbasehart@mednet.ucla.edu

Principal Investigator:

Travis Courtney, MD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-02-05.