Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.
Participants must have a histologically or cytologically confirmed diagnosis of metastatic malignancy or must have preliminary histology or cytology consistent with a diagnosis of metastatic malignancy.
Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist.
Participants must have undergone, within the past 13 days, or are planned to undergo minimally invasive or open surgery for the management of a spine metastasis.
Disease at any spine level is allowed.
Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above).
Primary malignancy of the spine (examples: chordoma or sarcoma).
Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher).
Involvement of 3 or more contiguous spinal levels.
Parallel
Stereotactic Body Radiation Therapy (SBRT)
RadiationUndergo radiation
Computed Tomography (CT) Simulation
Procedure/SurgeryUndergo imaging
Magnetic Resonance Imaging (MRI)
Procedure/SurgeryUndergo imaging
Questionnaires
BehavioralParticipant complete health related, quality of life questionnaire (HRQoL)
Local Control (LC) Rate
Local control (LC) is defined as the time from SBRT radiotherapy to metastatic lesions (event) within the SBRT treatment field with stable or decreased size as measured by a board-certified radiologist on follow-up imaging. Participants without any documented events or death will be censored. Estimates and confidence interval will be reported using the Kaplan Meier method.
Median Wound Complication Rate
Wound complication rate is defined as the rate of participants with wound complications by Centers for Disease Control and Prevention (CDC) criteria. Estimates and the 95% confidence interval will be reported using exact binomial confidence interval (CIs).
Proportion of Participants with Treatment-emergent Adverse Events (TrAE)
Proportion of participants with treatment-emergent adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) will be reported.
Median Progression-Free Survival (PFS)
PFS is defined as the time after enrollment to radiographic progression by RECIST 1.1 criteria on MRI, CT, or Positron Emission Tomography/Computed Tomography (PETCT) at any site of disease, primary or metastatic, or any clinical evidence of progression. Tumor progression is defined as any increase in size within the radiation treatment field (determined by a radiologist), not consistent with or attributable to radiation treatment effect. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Median Progression-Free Survival (PFS)
PFS is defined as the time after enrollment to radiographic progression by RECIST 1.1 criteria on MRI, CT, or PETCT at any site of disease, primary or metastatic, or any clinical evidence of progression. Tumor progression is defined as any increase in size within the radiation treatment field (determined by a radiologist), not consistent with or attributable to radiation treatment effect. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
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