About this trial
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease
Metastatic spine involvement documented by imaging
Involvement of maximum 3 contiguous vertebral bodies at the index site
Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
SBRT to the spine
RadiationStereotactic body radiation therapy (SBRT) administered to spine metastases
Treatment groups
Trial outcomes
Primary outcomes
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
Assess the efficacy of spine SBRT alone in controlling spine metastases
Secondary outcomes
Reduction in epidural tumor volume
Percent reduction of epidural volume of the treated metastatic lesions
Changes on Neck Disability index
The Neck Disability Index measures neck pain and disabilities in patients with neck pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome.
Changes on Oswestry Low Back Disability Questionnaire
The Oswestry Disability Index measures disability in patients with low back pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome.
Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
The EuroQol 5D-5L questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each health dimension is scored from 1 to 5, with 1 indicating a better health state, and 5 the worse state possible. Respondents also indicate their overall health status on visual analogue score, with values ranging from 0 (worst health imaginable) to 100 (best health imaginable)
Sponsors and contacts
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Stony Brook University
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborator