Evidence map›Paper›PMID 39709372›Full record

ArticleBMC cancer2024

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.

P Travis Courtney, Milisuryani L Santoso, Ricky R Savjani, Vishruth K Reddy, Wanxing Chai-Ho, Maria A Velez Velez, Deborah J Wong, Christy Palodichuk, T Vincent Basehart, Dylan P O'Connell and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06572423 (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06572423 narecruitingnot on this map

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

TypeinterventionalSponsorJonsson Comprehensive Cancer CenterRan2024 to 2029Enrolled43ConditionsHead and Neck Carcinoma, Localized Head and Neck Carcinoma, Metastatic Head and Neck Carcinoma, Recurrent Head and Neck CarcinomaArmsPersonalized ultrafractionated stereotactic adaptive radiotherapy, Volume Modulated Arc Therapy, Computed Tomography, Positron Emission Tomography, Magnetic Resonance Imaging
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

P Travis CourtneyDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA. PCourtney@mednet.ucla.edu.
Milisuryani L SantosoDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
Ricky R SavjaniDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
Vishruth K ReddyDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
Wanxing Chai-HoDepartment of Medical Oncology, University of California, Los Angeles, USA.
Maria A Velez VelezDepartment of Medical Oncology, University of California, Los Angeles, USA.
Deborah J WongDepartment of Medical Oncology, University of California, Los Angeles, USA.
Christy PalodichukDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
T Vincent BasehartDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
Dylan P O'ConnellDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
Minsong CaoDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.
Donatello TelescaDepartment of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, USA.
Robert K ChinDepartment of Radiation Oncology, University of California, 200 Medical Plaza Driveway, Suite #B265, Los Angeles, CA, 90025, USA.

Funding

UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Yvonne Yu-Hsuan Chen · 2017 to 2026
$25.2M
NCI NIH HHS P50 CA211015
6 · The paper itself

Abstract

backgroundMany patients with head and neck cancer are not candidates for standard of care definitive treatments though often require palliative treatments given the frequent symptoms associated with head and neck cancer. While existing palliative radiotherapy regimens can provide adequate symptom control, they have limitations particularly with respect to local control which is becoming more important as advances in systemic therapy are improving survival. Personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) is a novel radiotherapy regimen which leverages advances in radiotherapy treatment technology and extended interfraction intervals to enable adaptive radiotherapy and possible synergy with the immune system. Additionally, HyperArc© (Varian Medical Systems, Inc.) radiotherapy planning software allows for safe dose-escalation to head and neck tumors.

methodsThis single-arm phase II study will prospectively evaluate PULSAR with HyperArc© software for palliative treatment of head and neck cancer. Patients with de novo or recurrent, localized or metastatic, head and neck cancer who are ineligible for or decline standard of care definitive treatments are eligible for enrollment. Forty-three patients will receive an 11 Gray fraction of radiation every two weeks for a total of five fractions and dose of 55 Gy. Adaptive radiotherapy planning is permitted. A safety and feasibility evaluation will be performed after enrollment of the first fifteen patients whereby the trial will be closed if five or more patients experience a CTCAEv5.0 grade 3 or 4 or any patient experiences a grade 5 toxicity probably attributable to PULSAR during or within three months after its completion. The primary endpoint is one-year local head and neck tumor control. Secondary endpoints include safety, disease progression-free and overall survival, symptomatic impact, frequency of re-simulation and/or adaptive planning, and radiation dosimetry of PULSAR. Additionally, enrolled patients are permitted to receive cancer-directed systemic therapy, including immunotherapy, during PULSAR which may allow for the analysis of the safety and efficacy of this combination. DISCUSSION: The PULS-Pal trial is the first prospective study of PULSAR with HyperArc© software for head and neck cancer. We hypothesize that this radiotherapy regimen will lead to improved local tumor control compared with historical controls in patients undergoing palliative radiotherapy for head and neck cancer.

trial registrationClinicaltrials.gov identifier: NCT06572423 . Date of registration: August 28th, 2024.

Indexed as

Dose Fractionation, RadiationHead and Neck NeoplasmsPalliative CareRadiosurgeryAdultAgedClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedPrecision MedicineProspective StudiesRadiotherapy Planning, Computer-AssistedHead and neck cancerPalliative radiotherapyPersonalized Ultrafractionated stereotactic adaptive radiotherapy (PULSAR)Stereotactic body radiotherapy (SBRT)

Identifiers

PMID39709372
PMCPMC11662514

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Registered trials

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