Stereotactic Body Radiotherapy: Postoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction).
Study summary
This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. This treatment uses higher doses of radiation in fewer sessions (hypofractionated stereotactic body radiotherapy) delivered precisely by the Edge machine to target remaining tumor cells while protecting the spinal cord. The study aims to see if this approach improves local tumor control, improves neurological function, shortens treatment duration, and improves quality of life in these patients. The study is observational, meaning patients receive standard care, and data is collected to evaluate the outcomes.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18 to 80 years, any sex.
2. Karnofsky Performance Status (KPS) \>= 60 or ECOG Performance Status \<= 2.
3. Confirmed spinal metastases from solid tumors by pathology or imaging (MRI/CT).
4. Postoperative imaging confirming residual epidural spinal cord compression (MESCC) requiring adjuvant radiotherapy.
5. Number of lesions \<= 5, and maximum diameter of a single lesion \<= 5 cm.
6. Interval between surgery and radiotherapy \<= 4 weeks.
7. Signed informed consent and willingness to participate in the study.
Exclusion Criteria:
1. Uncontrolled primary tumor (e.g., extensive metastasis or progressive disease).
2. Concurrent brain metastases or other active malignancies.
3. Pathological fracture or severe spinal instability requiring emergency surgical intervention.
4. Prior cumulative spinal cord radiation dose exceeding the tolerance threshold (e.g., previous spinal cord Dmax \>= 45 Gy).
5. Contraindications to radiotherapy (e.g., severe cardiopulmonary dysfunction, coagulation disorders).
6. Severe postoperative complications (e.g., infection, poor wound healing) requiring delayed radiotherapy.
7. Incomplete or unreliable medical records from external hospitals.
8. Pregnant or lactating women.
Primary outcome measure(s)
Local Control Rate (LC) — 3 months post-treatment Proportion of patients with local tumor control, assessed by MRI showing residual tumor volume changes at 3 months post-treatment.
Trial sites (1)
Facility
City
Region
Status
300060
Tianjin
Tianjin Municipality
Recruiting
More Tianjin Medical University Cancer Institute and Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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