One-visit, simulation-free single-dose radiation for painful bone metastases

A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Utah (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT07202273 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

Inclusion Criteria:

* Participant aged ≥ 18 years.
* Diagnosis of any cancer with one to two 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. 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 this trial is running

Salt Lake City, Utah

• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Rachel Kingford

Conditions Bone Metastases