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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation-free, single-fraction palliative radiation therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simulation-free, single-fraction palliative radiation therapy | Radiation | Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Kingford | Contact | 8015850115 | Rachel.kingsford@hci.utah.edu | |
| Shane Lloyd, MD | Contact | 8015850255 | Shane.lloyd@hci.utah.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| 30 days |