Recruiting NCT07202273
Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: simulation-free, single-fraction palliative radiation therapy.
- Who it may be relevant to
- Registry conditions: Bone Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)
Overview
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
- Radiation 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.
Primary outcome measures
- To assess the rate at which the intervention is delivered with fidelity to protocol. [Time frame: 1 day]
Secondary outcome measures (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. [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Huntsman Cancer Institute/University of Utah — Salt Lake City
Identifiers
NCT: NCT07202273 · HCI193478