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

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

Interventions

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.

RADIATION

Volume Modulated Arc Therapy

Use HyperArc technology

PROCEDURE

Computed Tomography

Undergo CT simulation for radiation planning

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Best Practice

Undergo standard of care

BEHAVIORAL

University of Washington Quality of Life Scale, Version 4

Complete questionnaire

BEHAVIORAL

Functional Assessment of Cancer Therapy-Head & Neck

Complete questionnaire

Sponsors & Collaborators

• Varian Medical Systems

  collaborator INDUSTRY

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-25

Primary Completion

2028-12-16

Completion

2029-12-16

FDA Device

Yes

Countries

• United States

Study Locations