Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT)
  • Computed Tomography (CT) Simulation
  • Magnetic Resonance Imaging (MRI)
  • Questionnaires

Treatment groups

50 Participants
are divided into 2 treatment groups