A Phase 2 Study of Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
University of California, San Francisco
Summary
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the local control rate (LC) of treated metastatic sites in patients who undergo surgery for spinal metastasis followed by short interval postoperative spine Stereotactic Body Radiation Therapy (SBRT). SECONDARY OBJECTIVE: I. Evaluate the postoperative wound complication rate in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT. II. Determine the radiation toxicity of short-interval postoperative spine SBRT in participants. III. Determine the progression-free survival (PFS) in participants who underg…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist. 3. 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. 4. Disease at any spine level is allowed. 5. Prior therapy 1. There is no limit on the number of…
Interventions
- RadiationStereotactic Body Radiation Therapy (SBRT)
Undergo radiation
- ProcedureComputed Tomography (CT) Simulation
Undergo imaging
- ProcedureMagnetic Resonance Imaging (MRI)
Undergo imaging
- BehavioralQuestionnaires
Participant complete health related, quality of life questionnaire (HRQoL)
Location
- University of California, San FranciscoSan Francisco, California