One-visit, simulation-free single-dose radiation for painful bone metastases
Official title: A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)
Run by University of Utah · NCT07202273 · Data updated 2026-11-12
This trial tests whether adults with one or two painful bone metastases can get pain-relieving radiation in a single visit using a simulation-free planning approach.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2028 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07202273 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with cancer who have one or two painful, radiographically visible bone metastases amenable to single-fraction radiation, ECOG 0–2, and a diagnostic CT within 60 days.
✕Probably not a fit
Patients with more than two painful lesions, lesions requiring complex multi-fraction planning or surgical stabilization, poor performance status, or without an adequate recent CT are unlikely to benefit from this single-fraction, simulation-free approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study delivers single-fraction palliative radiation to one or two painful bone metastases in adults using a simulation-free workflow that relies on recent diagnostic CT images for planning. Eligible participants are adults with one to two treatable painful bone lesions, ECOG performance status ≤ 2, and a diagnostic CT of the target obtained within 60 days. Treatment is delivered in a single in-person visit without a separate simulation appointment, with the treating physician determining candidacy and dose per standard palliative practice. Outcomes focus on feasibility, timely symptom relief, and monitoring for safety and treatment-related effects.
Why it matters
Potential benefit: If successful, this approach could shorten clinic visits and speed access to pain relief by delivering palliative radiation in a single appointment without a separate simulation visit.
How similar studies have gone: Single-fraction palliative radiation for bone metastases has a strong track record for pain relief, but simulation-free, single-visit workflows are a newer approach with limited published data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Where it's running
-
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Rachel Kingford
- Email: Rachel.kingsford@hci.utah.edu
- Phone: 8015850115
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.