Ireland
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Active, not recruiting Not applicable

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

NCT05524064 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2023-03-08
Last updated
2026-08-19

Condition(s) studied

Bone Metastases in the Thorax

Investigational drug(s) / intervention(s)

FLASH Radiotherapy

FLASH Radiotherapy: A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).

Study summary

The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient age at least 18 years * 1 to 3 painful bone metastasis(-es) requiring treatment, in the ribs, clavicles, scapulae, or sternum (if more than one metastasis can be treated within the same treatment field, it will be counted as one metastatic site for the purpose of trial treatment). * Bone metastases that can be treated within a field size up to 7.5 cm x 30 cm without overlap of radiation fields * Life expectancy \>6 months (in the judgement of the investigator) * Patients who are able to comply with the protocol * Provision of signed and dated informed consent form * Clinically acceptable treatment plan Exclusion Criteria: * More than 3 painful bone metastases of the thorax requiring palliative radiotherapy (if more than one metastasis can be treated within the same treatment field, it will be counted as one metastatic site for the purpose of trial treatment). * Overlap of FLASH radiation fields with any previous or planned radiation fields to the same site * Patients with pathologic bone fractures in the treatment field * Patients with metal implants in the treatment field * Patients with symptomatic pneumonitis at the time of screening, or a history of symptomatic radiation pneumonitis * Patients with known contraindications to thoracic radiation * Patients who received or will receive cytotoxic chemotherapy and/or any prescribed systemic therapy known to impact tissue response to radiation, within 2 weeks prior or 1 week following their planned radiation treatment * Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment that, in the judgement of the investigator, might compromise interpretation of pain response * Patients with persistent toxicity \> Grade 1 from prior systemic therapy within the proposed treatment field (with the exception of alopecia and peripheral neuropathy) * Patients with pacemakers or other implanted devices at risk of malfunction during radiotherapy * Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation * Patients at known risk of enhanced normal tissue sensitivity to radiotherapy due to inherited predisposition or documented comorbidity that might lead to hypersensitivity to ionizing radiation * Patients enrolled in any other clinical studies that the investigator believes to be in conflict with this clinical investigation. * Patients who are pregnant or nursing

Primary outcome measure(s)

  • Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. — Assessed from start of treatment until 6 months post treatment.
    Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.
  • Assessment of pain relief using patient reported pain questionnaire for overall pain score — Change from baseline pain overall at 3 months.
    Patient reported pain overall
  • Assessment of pain relief using patient reported pain questionnaire for pain at treated site — Change from baseline pain at treated site at 3 months.
    Patient reported pain at treated site
  • Use of pain medication — Change from baseline pain medication usage at 3 months.
    Capture dose and frequency of pain medication usage or pain medication changes.

Trial sites (2)

FacilityCityRegionStatus
OSF Healthcare Saint Francis Medical Center Peoria Illinois
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05524064 on ClinicalTrials.gov ↗ ← All trials in the USA