Recruiting

Palliative Radiation

Sponsor:

University of Utah

Code:

NCT07202273

Conditions

Bone Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

simulation-free, single-fraction palliative radiation therapy

Study Details

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.

Conditions

Bone Metastases

Study ID

NCT07202273

Start date

Nov 3, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Simulation-free, single-fraction palliative radiation therapy

Interventions

simulation-free, single-fraction palliative radiation therapy

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.

Primary outcome measure

  • To assess the rate at which the intervention is delivered with fidelity to protocol. [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Rachel Kingford

8015850115Rachel.kingsford@hci.utah.edu

Shane Lloyd, MD

8015850255Shane.lloyd@hci.utah.edu

Locations

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

801-585-0115Rachel.kingsford@hci.utah.edu

Shane Lloyd, MD

801-585-0255Shane.lloyd@hci.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-13.