Bone Metastases
Conditions
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.
Interventions
RADIATIONsimulation-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.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the rate at which the intervention is delivered with fidelity to protocol. | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 days | 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. |
Countries
United States
Contacts
CONTACTRachel Kingford
CONTACTShane Lloyd, MD
Outcome results
None listed