Postoperative Edge SBRT for Spinal Metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, observational cohort study evaluating postoperative Edge (RapidArc) SBRT in solid-tumor spinal metastases with residual MESCC. Fifty adult patients will receive 35 Gy in 5 fractions delivered with sub-millimeter precision to maximize tumor control while protecting the spinal cord. Primary outcomes are local control and neurological improvement at 3 months; secondary outcomes include longer-term local control, neurological deterioration-free survival, overall survival, and quality of life. Adverse events such as radiation myelitis and esophagitis will be monitored, and data will be analyzed using standard survival and regression methods. The study uses strict inclusion/exclusion criteria focused on limited lesion burden and adequate performance status to assess real-world postoperative radiotherapy performance with the Edge system.

Why it matters

Who can join: the full rules

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.

Where it's running

• 300060
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Xu Liming, MD — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Xu Liming, MD
• Email: xuliming@tjmuch.com
• Phone: 86-22-23340123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.