Definitive Radiation for High-Risk Spine Metastases

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStony Brook University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • SBRT to the spine

    Radiation

    Stereotactic body radiation therapy (SBRT) administered to spine metastases

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: SBRT to the spineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT

Assess the efficacy of spine SBRT alone in controlling spine metastases

Time frame
6 months

Secondary outcomes

1

Reduction in epidural tumor volume

Percent reduction of epidural volume of the treated metastatic lesions

Time frame
3 months
2

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.

Time frame
1 months, 3 months, 6 months
3

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.

Time frame
1 months, 3 months, 6 months
4

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)

Time frame
1 months, 3 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

The University of Texas Health Science Center at San Antonio

Collaborator