Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
ConditionBone Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
simulation-free, single-fraction palliative radiation therapy
RadiationRadiation 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Simulation-free, single-fraction palliative radiation therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the rate at which the intervention is delivered with fidelity to protocol.
To provide proof-of-concept that patients can be treated with simulation-free, single-fraction palliative radiation therapy with only a single in-person visit to Huntsman Cancer Hospital (HCH). This will be defined as receiving simulation-free, single-fraction radiation therapy with documented real-time approval by the radiation oncologist, medical physicist, and radiation therapist that the treatment adequately covers the target without unreasonable or unsafe differences.
Time frame
1 daySecondary outcomes
1
The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline.
To assess whether the percentage of patients who experience an improvement in patient-reported quality of life related to bone pain after simulation-free, single-fraction palliative radiation therapy is consistent with a historical standard of 70%. Improved will be defined as an increase in total FACT-BP score of ≥ 2.
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov