NCT07202273NARecruiting
Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
University of Utah
Start Date
11/3/2025
Completion Date
10/1/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
RADIATION
simulation-free, single-fraction palliative radiation therapy
Conditions
Bone Metastases
Locations
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States