Phase 2 N=35 Treatment

Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

Metastatic Cancer · Pain · Unspecified Adult Solid Tumor, Protocol Specific

Bottom Line

View on ClinicalTrials.gov: NCT00855803 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Mar 2022

Primary outcome: Primary: Pain Response as Measured by VAS at 3 Months — 8; 12; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: radiation (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Response as Measured by VAS at 3 Months	8; 12; 1	—
SECONDARY Pain Response	10; 10; 5	—
SECONDARY Overall Survival	9	—
SECONDARY Daily Function	5.8; 6.0	—
SECONDARY Quality of Life Questionnaire Responses	35; 29; 21; 16; 7	—

Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis. PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.

Eligibility Criteria

Eligibility:

Inclusion:

Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
Patients must have a VAS of ≥4 at any of the planned treatment sites
Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
Narcotic pain prescription and usage information must be available and documented
Patients must sign study specific consent
Above the age of 18
For women of childbearing age a negative pregnancy test is required
Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
Zubrod score of 0-2

Exclusion:

Patients who have been non-ambulatory for more than 7 days
Patients with compression fractures
Spine instability requiring fixation
Patients with paraspinal extension
Patients with bony fragments
Planned systemic treatment within one week after treatment.
Absence of pathological diagnosis of cancer
Chemotherapy within one week of treatment
Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Patient had a transmural myocardial infarction within the last 6 months
Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
Platelet count is < 50,000
History of significant psychiatric illness

Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00855803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.