This prospective, multicenter, single-arm phase II clinical trial is designed to enroll patients with spinal metastases classified as Bilsky grade 1c-3 who will receive stereotactic body radiation therapy (SBRT). The objective of this study is to assess the efficacy and safety of SBRT in the treatment of spinal metastases with epidural spinal cord compression (Bilsky grade 1c-3).
· Participants must be capable of understanding and voluntarily signing the written informed consent form;· Age ≥ 18 years;· (ECOG) performance status score ≤ 3;· The primary tumor is histologically or cytologically confirmed as a solid malignant tumor (excluding multiple myeloma, lymphoma, and germ cell tumors);· Has clear radiological evidence of spinal metastases;· Has acceptable spinal stability (Spinal Instability Neoplastic Score [SINS] ≤ 6, or between 7-12 but assessed as stable by surgical consultation), or has previous spinal instability that has been determined to be stable after surgical intervention;· Bilsky grade of spinal metastases confirmed by magnetic resonance imaging (MRI) as 1c-3;· Number of consecutive involved vertebral segments ≤ 3;· The involved vertebral level is above the conus medullaris;· Laboratory tests indicate adequate organ function.
·Histologically confirmed primary spinal tumor or central nervous system disease;· Intramedullary lesions;· Prior radiotherapy to the same vertebral level;· Presence of contraindications to MRI examination;· Unable to lie flat for ≥ 30 minutes;· Presence of other severe comorbidities, such as uncontrollable cardiovascular disease, pulmonary disease, or other organ dysfunction, with poor overall health status and intolerance to treatment;· Pregnant or breastfeeding women;· Currently participating in other interventional clinical research treatments, or having received other investigational drugs or investigational device treatments within 4 weeks prior to the first treatment.
Single group
SBRT
RadiationSBRT treatment for patients with spinal cord metastasis and epidural spinal cord compression (Bilsky grade 1c-3). All patients will be treated using the CyberKnife system and treated once daily within 1-2 weeks.
Local failure
defined as radiographic and/or clinical progression within the radiotherapy target volume.
OS
defined as the time from randomization (or study entry) to death from any cause.
Click on the lead sponsor to view all of their trials.
