Evidence map›Paper›PMID 38475815›Full record

ArticleRadiation oncology (London, England)2024

FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach.

E C Daugherty, Y Zhang, Z Xiao, A E Mascia, M Sertorio, J Woo, C McCann, K J Russell, R A Sharma, D Khuntia and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Radiation oncology (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05524064 (FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax), which is not on this map. Cited by 69 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 4 pooled it
45.2field-weighted citation impact, top 1% of its field
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.

NCT05524064 naactive not recruitingnot on this map

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

TypeinterventionalSponsorVarian, a Siemens Healthineers CompanyRan2023 to 2027Enrolled10ConditionsBone Metastases in the ThoraxArmsFLASH Radiotherapy
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 4 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. From developmental origins to relapse: molecular and therapeutic insights in medulloblastoma.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026
    Review
  13. Volumetric FLASH dosimetryPhysics in medicine and biology · 2026
    Article
  14. Article
  15. Cardiac substructure dosimetry in thoracic radiotherapy: moving beyond mean heart dose and toward precision cardiac risk mitigation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article

9 more citing papers are in PubMed but not listed here.

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

14 authors at 4 institutions in 1 country.

E C DaughertyDepartment of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.
Y ZhangDepartment of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.
Z XiaoDepartment of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.
A E MasciaDepartment of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.
M SertorioDepartment of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.
J WooVarian, a Siemens Healthineers Company, Palo Alto, USA.
C McCannVarian, a Siemens Healthineers Company, Palo Alto, USA.
K J RussellVarian, a Siemens Healthineers Company, Palo Alto, USA.
R A SharmaVarian, a Siemens Healthineers Company, Palo Alto, USA.
D KhuntiaVarian, a Siemens Healthineers Company, Palo Alto, USA.
J D BradleyDepartment of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA.
C B SimoneDepartment of Radiation Oncology, New York Proton Center , New York, NY, USA.
J C BrenemanDepartment of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.
J P PerentesisCancer and Blood Disease Institute , Cincinnati Children's Hospital , Cincinnati, OH, USA. john.perentesis@cchmc.org.
University of Cincinnati · USSiemens Healthcare (United States) · USNew York Proton Center · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFLASH therapy is a treatment technique in which radiation is delivered at ultra-high dose rates (≥ 40 Gy/s). The first-in-human FAST-01 clinical trial demonstrated the clinical feasibility of proton FLASH in the treatment of extremity bone metastases. The objectives of this investigation are to assess the toxicities of treatment and pain relief in study participants with painful thoracic bone metastases treated with FLASH radiotherapy, as well as workflow metrics in a clinical setting.

methodsThis single-arm clinical trial is being conducted under an FDA investigational device exemption (IDE) approved for 10 patients with 1-3 painful bone metastases in the thorax, excluding bone metastases in the spine. Treatment will be 8 Gy in a single fraction administered at ≥ 40 Gy/s on a FLASH-enabled proton therapy system delivering a single transmission proton beam. Primary study endpoints are efficacy (pain relief) and safety. Patient questionnaires evaluating pain flare at the treatment site will be completed for 10 consecutive days post-RT. Pain response and adverse events (AEs) will be evaluated on the day of treatment and on day 7, day 15, months 1, 2, 3, 6, 9, and 12, and every 6 months thereafter. The outcomes for clinical workflow feasibility are the occurrence of any device issues as well as time on the treatment table. DISCUSSION: This prospective clinical trial will provide clinical data for evaluating the efficacy and safety of proton FLASH for palliation of bony metastases in the thorax. Positive findings will support the further exploration of FLASH radiation for other clinical indications including patient populations treated with curative intent. REGISTRATION: ClinicalTrials.gov NCT05524064.

Indexed as

Bone NeoplasmsProtonsHumansPainProspective StudiesThoraxProtonsAdverse effectsEfficacyFLASH radiotherapyFLASH workflowPain reliefProton therapySafetyThoracic bone metastasesUltra-high dose rate

Identifiers

PMID38475815
PMCPMC10935811
OpenAlexW4392683786

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.