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

Not Applicable

Active, not recruiting

• Conditions: Bone Metastases in the Thorax

• Registration Number: NCT05524064
• Lead Sponsor: Varian, a Siemens Healthineers Company

Brief 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.

Detailed Description

This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.

Study Timeline

• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-09-01
• Study Start: 2023-03-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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.
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.

Secondary Outcome Measures

Name	Time	Method
Workflow feasibility - delays in study treatment	Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.	Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 10 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment).
Workflow feasibility - time on table	Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.	Total subject treatment time on table.

Trial Locations

Locations (2)

OSF Healthcare Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States