Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)
NCT Number: NCT06572423
Acronym: PULS-Pal
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
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|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
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: Varian Medical Systems
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-14
Completion Date: 2029-09-16
Locations: University of California at Los Angeles, Los Angeles, California, 90095, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Grade 3 or higher treatment-related toxicity, According to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Will be performed across the whole cohort, as well as separate analysis stratifying patients by Human Papillomavirus/p16 status., Within 24 months after treatment completion|Disease progression free survival (PFS), Disease progression of any type will be determined clinically and/or radiographically as applicable. Time to disease progression will be reported descriptively for each patient. One-year disease 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 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), The Kaplan-Meier method will be used to summarize overall survival., 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, Represented by changes from baseline in the pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood, anxiety, intimacy, fear of cancer recurrence, overall health-related quality of life, and overall quality of life domains. Each domain ranges from 0-100 with higher scores meaning a better outcome. Changes will be analyzed with respect to whether they represent minimally important differences., From baseline up to 24 months|Longitudinal patient reported outcomes on the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Questionnaire, Represented by changes from baseline in the physical well-being, social/family well-being, emotional well-being, functional well-being domains and additional concerns. Each domain has multiple specific questions with a 5 point Likert-type scale for responses. Changes will be analyzed with respect to whether they represent minimally important differences., From baseline up to 24 months|Radiation therapy dosimetry, Will be performed on patients included in analysis sets FAS and EAS across the whole cohort, as well as separate analyses stratifying patients by Human Papillomavirus/p16 status., through study completion, on average of 24 months|Radiation therapy planning, Frequency of re-simulation and/or adaptive planning required with PULSAR, through study completion, on average of 24 months|Incidence of adverse events (AE), Safety analyses will be performed for patients included in analysis set Statistical Analysis Software (SAS), From baseline up to 24 months