Bone Metastases in the ThoraxFAST-02NCT05524064
FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax
A study testing FLASH Radiotherapy in people with Bone Metastases in the Thorax, run by Varian, a Siemens Healthineers Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases in the Thorax
- What is being tested?
- FLASH Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2023to 1 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
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.
Read the 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.
- Conditions
- Bone Metastases in the Thorax
- Being tested
- FLASH Radiotherapy
- Keywords
- FLASH radiotherapy, Radiation treatment, Proton, Bone metastasis, Pain relief, Toxicities, Thorax, Ultra-high dose rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLASH RadiotherapyRadiation
A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (>40 Gy/s).
| Study group | Role | What they receive |
|---|---|---|
| FLASH radiotherapy for painful bone metastasis(-es) | Experimental | FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment. Receives: Radiation: FLASH Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline pain medication usage at 3 months.
Secondary outcomes (2)
Workflow feasibility - time on table
Total subject treatment time on table.
Measured: 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).
Measured: Will be assessed on day of treatment delivery which occurs within 2-4 weeks of subject enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start8 Mar 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Metastases in the ThoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm prospective study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Perentesis, MD, Principal investigator, Medical Director Cincinnati Children's/UC Health Proton Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524064
- Sponsor's protocol ID
- VAR-2022-03
- Acronym
- FAST-02
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Daugherty EC, Zhang Y, Xiao Z, Mascia AE, Sertorio M, Woo J, McCann C, Russell KJ, Sharma RA, Khuntia D, Bradley JD, Simone CB 2nd, Breneman JC, Perentesis JP. FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach. Radiat Oncol. 2024 Mar 12;19(1):34. doi: 10.1186/s13014-024-02419-4.
PubMed 38475815