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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT06572423
Status
Recruiting
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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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized ultrafractionated stereotactic adaptive radiotherapy — PROCEDURE
    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 — RADIATION
    Use HyperArc technology
  • Computed Tomography — PROCEDURE
    Undergo CT simulation for radiation planning
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Best Practice — OTHER
    Undergo standard of care
  • University of Washington Quality of Life Scale, Version 4 — BEHAVIORAL
    Complete questionnaire
  • Functional Assessment of Cancer Therapy-Head & Neck — BEHAVIORAL
    Complete questionnaire

Study Details

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.

Key Dates

Start date
Oct 25, 2024
Status verified
Feb 2026
Primary completion
Dec 16, 2028
Completion
Dec 16, 2029

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia90095
Mili Santoso
[email protected]
310-267-2153
Vincent Basehart
[email protected]
3102678954
Travis Courtney, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California at Los Angeles· Los Angeles, CA

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