Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

NCT ID: NCT07202273

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2028-10-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simulation-free, single-fraction palliative radiation therapy

Group Type: EXPERIMENTAL

simulation-free, single-fraction palliative radiation therapy

Intervention Type: RADIATION

Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Kingford

Role: CONTACT

Rachel.kingsford@hci.utah.edu

8015850115

Shane Lloyd, MD

Role: CONTACT

Shane.lloyd@hci.utah.edu

8015850255

Facility Contacts

Rachel Kingsford

Role: primary

Rachel.kingsford@hci.utah.edu

801-585-0115

Shane Lloyd, MD

Role: backup

Shane.lloyd@hci.utah.edu

801-585-0255

Other Identifiers

HCI193478

Identifier Type: -

Identifier Source: org_study_id