CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 43 target
Drug / intervention
Personalized ultrafractionated stereotactic adaptive radiotherapy +7 moreprocedure
Likely dose
Not stated in record
Key inclusion· 9
  • Age ≥18 years
  • Primary, recurrent, localized, or metastatic head and neck cancer (AJCC 8th Edition stages I-IV)
  • Pathologic confirmation required for primary diagnosis; may be waived for recurrent/metastatic cases if not standard of care
  • Ineligible for or declines standard of care definitive treatment
Key exclusion· 3
  • Pregnant or breast-feeding
  • More than 1 prior radiation treatment course to treatment area, or ≥1 prior course if <6 months since completion
  • Comorbidity or condition limiting full protocol compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06572423
NCT06572423N/ARecruitingOn TrackUpdated 4mo ago

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

Jonsson Comprehensive Cancer Center·interventional·Posted Aug 27, 2024·Updated Feb 5, 2026

In Brief

A clinical study evaluating Personalized ultrafractionated stereotactic adaptive radiotherapy, Volume Modulated Arc Therapy, and 6 other interventions for Head and Neck Carcinoma and 3 related conditions. Currently recruiting, targeting 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ARecruiting
202520262027202820292030
First PostedAug 27, 2024
Enrollment StartOct 25, 2024
Primary CompletionDec 16, 2028
Study CompletionDec 16, 2029
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 1.8 years agoPrimary completion in 2.5 years

Interventions

Personalized ultrafractionated stereotactic adaptive radiotherapyprocedure

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 Therapyradiation

Use HyperArc technology

Computed Tomographyprocedure

Undergo CT simulation for radiation planning

Positron Emission Tomographyprocedure

Undergo PET

Magnetic Resonance Imagingprocedure

Undergo MRI

Best Practiceother

Undergo standard of care

University of Washington Quality of Life Scale, Version 4behavioral

Complete questionnaire

Functional Assessment of Cancer Therapy-Head & Neckbehavioral

Complete questionnaire