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In light of the increasing experience with magnetic resonance image-guided radiotherapy (MRgRT) and adaptive planning and advances in magnetic resonance (MR)-only planning, the investigators propose here to evaluate the feasibility and safety of same-session MR-only simulation and treatment with SMART for spinal metastases. Although spine SBRT is a standard-of-care treatment modality, this expedited same-session MR-only simulation and treatment with SMART workflow is novel. Previously, delivery of spine SBRT has typically required several days from time of consultation to simulation and then 1-2 weeks from simulation to the initiation of treatment. On this proposed study, patients will not undergo computed tomography (CT) simulation and will instead have same-session MR-only simulation and treatment planning, on-table, using SMART. In this manner, patients would initiate treatment within just several days from the consult. Feasibility of the workflow will be defined as successful delivery of the first fraction of same-session MRI-only simulation and treatment with SMART on the first on-table attempt for at least 70% of patients. Patients will be treated in five fractions over 1-2 weeks. Although the long-term goal will be to achieve a significantly shortened time from consult to treatment as compared to traditional stereotactic body radiation therapy (SBRT) using simulation, the present study will be driven by short-term goals of workflow feasibility and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic MRI-guided Adaptive Radiotherapy | Experimental | -Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRIdian Linac System from ViewRay | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants to Receive Delivery of the First Fraction of Same-session MRI-only Simulation and Treatment With SMART on the First On-table Attempt | First on-table attempt of first fraction of radiation (an average of 1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford Robinson, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic MRI-guided Adaptive Radiotherapy | -Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2023 |
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| Stereotactic MRI-guided Adaptive Radiotherapy | Radiation | -The MR-linac will be delivering the radiation |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic MRI-guided Adaptive Radiotherapy | -Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants to Receive Delivery of the First Fraction of Same-session MRI-only Simulation and Treatment With SMART on the First On-table Attempt | Posted | Count of Participants | Participants | First on-table attempt of first fraction of radiation (an average of 1 day) |
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Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.
The following adverse events were not collected: grade 1-2 events regardless of relatedness, grade 3-4 events that predate SBRT, and grade 3-4 events that are not at least probably attributable to treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic MRI-guided Adaptive Radiotherapy | -Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected). | 1 | 10 | 2 | 10 | 1 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Disease progression | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Clifford Robinson | Washington University School of Medicine | 314-362-8567 | clifford.robinson@wustl.edu |
| May 7, 2024 |
| Prot_SAP_000.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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