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

August 17, 2026 updated by: Varian, a Siemens Healthineers Company
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.
Time Frame: 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.
Assessed from start of treatment until 6 months post treatment.
Assessment of pain relief using patient reported pain questionnaire for overall pain score
Time Frame: Change from baseline pain overall at 3 months.
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
Time Frame: Change from baseline pain at treated site at 3 months.
Patient reported pain at treated site
Change from baseline pain at treated site at 3 months.
Use of pain medication
Time Frame: Change from baseline pain medication usage at 3 months.
Capture dose and frequency of pain medication usage or pain medication changes.
Change from baseline pain medication usage at 3 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Workflow feasibility - time on table
Time Frame: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
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
Time Frame: 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).
Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Varian, a Siemens Healthineers Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Perentesis, MD, Medical Director Cincinnati Children's/UC Health Proton Therapy Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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