Spinal Metastases, Stereotactic Body Radiation Therapy (SBRT)
Conditions
Keywords
Stereotactic Body Radiation Therapy, Spinal metastases, epidural spinal cord compression
Brief summary
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).
Interventions
RADIATIONSBRT
SBRT 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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stereotactic body radiation therapy (SBRT) in patients with spinal metastases and epidural spinal cord compression (Bilsky grade 1c-3)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* · 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.
Exclusion criteria
* ·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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local failure | The time from randomization to local failure assessed up to 12 months | defined as radiographic and/or clinical progression within the radiotherapy target volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | the time from randomization to death from any cause assessed up to 12 months | defined as the time from randomization (or study entry) to death from any cause. |
Countries
China
Contacts
CONTACTHuanhuan Wang, MD
Outcome results
None listed