Status:
RECRUITING
Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
Lead Sponsor:
University of Utah
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07202273
Start Date
November 3 2025
End Date
October 1 2028
Last Update
November 5 2025
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112