This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02713269.
PRIMARY OBJECTIVE:
I. To document the rate of local control at 6 months in patients who receive a combination of thermal ablation and stereotactic spine radiosurgery (SSRS) for spine metastases with moderate to severe epidural involvement.
SECONDARY OBJECTIVES:
I. To determine local control at 1, 3, 9, 12, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.
II. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months.
IIa. Calculate decrease in epidural tumor volume (by volumetric measurements).
IIb. Calculate increase in thecal sac patency (by volumetric measurements and according to Bilsky method).
III. To determine overall survival at 6, 12, 18, and 24 months.
IV. To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines.
V. To assess the effect of treatment on quality of life (QOL), measured at 1 month and every 3 months after with validated outcome measure tools.
VI. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.
OUTLINE:
Patients undergo thermal ablation and computed tomography (CT)-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJing Li
