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

NCT06572423 | Recruiting DMC FDA Device

• 1 other identifier: 24-000663
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline up to 1 year

Secondary Outcomes (8)

• Grade 3 or higher treatment-related toxicity

  Within 24 months after treatment completion

• Disease progression free survival (PFS)

  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)

  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

  From baseline up to 24 months

• Longitudinal patient reported outcomes on the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Questionnaire

  From baseline up to 24 months

Study Arms (1)

Treatment (PULSAR and HyperArc)

EXPERIMENTAL

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

Interventions

Volume Modulated Arc Therapy RADIATION

Use HyperArc technology

Also known as: VMAT, Volumetric Modulated Arc Therapy

Treatment (PULSAR and HyperArc)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, PET, PET Scan, proton magnetic resonance spectroscopic imaging

Treatment (PULSAR and HyperArc)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, MRI

Treatment (PULSAR and HyperArc)

Best Practice OTHER

Undergo standard of care

Also known as: standard of care

Treatment (PULSAR and HyperArc)

Functional Assessment of Cancer Therapy-Head & Neck BEHAVIORAL

Complete questionnaire

Also known as: FACT Head and Neck Questionnaire, FACT-H&N Questionnaire

Treatment (PULSAR and HyperArc)

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.

Also known as: PULSAR

Treatment (PULSAR and HyperArc)

Computed Tomography PROCEDURE

Undergo CT simulation for radiation planning

Also known as: CAT, CAT Scan, Computed Axial Tomography, CT, CT Scan

Treatment (PULSAR and HyperArc)

University of Washington Quality of Life Scale, Version 4 BEHAVIORAL

Complete questionnaire

Also known as: UW QOL v4

Treatment (PULSAR and HyperArc)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (1)

• Courtney PT, L Santoso M, Savjani RR, K Reddy V, Chai-Ho W, Velez Velez MA, J Wong D, Palodichuk C, Basehart TV, P O'Connell D, Cao M, Telesca D, Chin RK. A phase II study of personalized ultrafractionated stereotactic adaptive radiotherapy for palliative head and neck cancer treatment (PULS-Pal): a single-arm clinical trial protocol. BMC Cancer. 2024 Dec 21;24(1):1564. doi: 10.1186/s12885-024-13303-5.

  PMID: 39709372 DERIVED

MeSH Terms

Interventions

DEAE-Dextran; Radiotherapy, Intensity-Modulated; Magnetic Resonance Spectroscopy; X-Rays; Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Dextrans; Glucans; Polysaccharides; Carbohydrates; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Travis Courtney, MD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mili Santoso

CONTACT

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

Vincent Basehart

CONTACT

3102678954; vbasehart@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 27, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): December 16, 2028
• Study Completion (Estimated): December 16, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)