Bone MetastasesSIM-FREE RTNCT07202273
Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
A study testing simulation-free, single-fraction palliative radiation therapy in people with Bone Metastases, run by University of Utah at 1 site in United States.
Trial summary
The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- simulation-free, single-fraction palliative radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participant aged ≥ 18 years.
- Diagnosis of any cancer with one to two sites of painful and treatable metastatic bone lesions.
- Bone metastases are causing pain or instability in the opinion of the treating investigator.
- Amenable to single fraction radiation therapy per the discretion of the treating physician.
- CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
- ECOG Performance Status ≤ 2.
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- Participants must adhere to the following sex and contraceptive/barrier requirements:
- If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy test are available for review before treatment.
- For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
- < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- ---≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago
- Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Evidence of spinal cord compression caused by the bone metastases to be treated.
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- Participants taking prohibited medications as described in Section 6.7.1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, Rachel.kingsford@hci.utah.edu
Shane Lloyd, MD, 801-585-0255, Shane.lloyd@hci.utah.edu
About this study
Official title: A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)
The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.
- Conditions
- Bone Metastases
- Being tested
- simulation-free, single-fraction palliative radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation-free, single-fraction palliative radiation therapyRadiation
Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy.
Up to two sites of bone metastases may be treated on trial (i.e. no more than two radiation portals). Each site may have multiple lesions.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-free, single-fraction palliative radiation therapy | Experimental | Not described Receives: Radiation: simulation-free, single-fraction palliative radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the rate at which the intervention is delivered with fidelity to protocol.
To provide proof-of-concept that patients can be treated with simulation-free, single-fraction palliative radiation therapy with only a single in-person visit to Huntsman Cancer Hospital (HCH). This will be defined as receiving simulation-free, single-fraction radiation therapy with documented real-time approval by the radiation oncologist, medical physicist, and radiation therapist that the treatment adequately covers the target without unreasonable or unsafe differences.
Measured: 1 day
Secondary outcomes (1)
The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline.
To assess whether the percentage of patients who experience an improvement in patient-reported quality of life related to bone pain after simulation-free, single-fraction palliative radiation therapy is consistent with a historical standard of 70%. Improved will be defined as an increase in total FACT-BP score of ≥ 2.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start3 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202273
- Sponsor's protocol ID
- HCI193478
- Acronym
- SIM-FREE RT
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)
- ClinicalTrials.gov ID
- NCT07202273
- Acronym / sponsor ID
- SIM-FREE RT / HCI193478
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation-free, single-fraction palliative radiation therapy | Experimental | Radiation: simulation-free, single-fraction palliative radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participant aged ≥ 18 years.
- Diagnosis of any cancer with one to two sites of painful and treatable metastatic bone lesions.
- Bone metastases are causing pain or instability in the opinion of the treating investigator.
- Amenable to single fraction radiation therapy per the discretion of the treating physician.
- CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
Key exclusion criteria (4 listed)
- Evidence of spinal cord compression caused by the bone metastases to be treated.
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- Participants taking prohibited medications as described in Section 6.7.1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulation-free, single-fraction palliative radiation therapyRadiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy. Up to two sites of bone metastases may be treated on trial (i.e. no more than two radiation portals). Each site may have multiple lesions. | Radiation | Simulation-free, single-fraction palliative radiation therapy |
Primary outcome
To assess the rate at which the intervention is delivered with fidelity to protocol.
Time frame: 1 day
To provide proof-of-concept that patients can be treated with simulation-free, single-fraction palliative radiation therapy with only a single in-person visit to Huntsman Cancer Hospital (HCH). This will be defined as receiving simulation-free, single-fraction radiation therapy with documented real-time approval by the radiation oncologist, medical physicist, and radiation therapist that the treatment adequately covers the target without unreasonable or unsafe differences.
1 secondary outcome
The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation-free, single-fraction palliative radiation therapy in people with Bone Metastases, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kingford (8015850115, Rachel.kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the rate at which the intervention is delivered with fidelity to protocol. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.