FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax (FAST-02)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Metastases in the Thorax
• Intervention / Treatment: Radiation: FLASH Radiotherapy

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Peoria, Illinois, United States, 61637
      • OSF HealthCare Saint Francis Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLASH radiotherapy for painful bone metastasis(-es); FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.	Radiation: 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workflow feasibility - time on table	Total subject treatment time on table.	Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
Workflow feasibility - delays in study treatment	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).	Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company
• Investigators: Principal Investigator: John Perentesis, MD, Medical Director Cincinnati Children's/UC Health Proton Therapy Center

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 21, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pain relief; Toxicities; Radiation treatment; Bone metastasis; Thorax; FLASH radiotherapy; Proton; Ultra-high dose rate
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Hematologic Diseases; Neoplastic Processes; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: VAR-2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No