Stereotactic body radiation therapy for spinal metastases with epidural compression

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 multicenter, single-arm phase II trial evaluating the efficacy and safety of stereotactic body radiation therapy (SBRT) for patients with Bilsky grade 1c-3 spinal metastases and epidural spinal cord compression. Eligible participants are adults with solid tumors, limited spinal involvement, and adequate organ function, receiving SBRT to the affected spine. The study focuses on gathering data on tumor control, symptom relief, and treatment-related safety in a real-world setting. Primary outcomes likely include local control and adverse events, with secondary observations on neurologic status and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Huanhuan Wang, MD
• Email: doctor_1188@163.com
• Phone: 022-23340123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pre-surgery focused radiation for spinal metastases.

  This trial will test whether short-course, focused radiation given before surgery can improve local tumor control and reduce pain and disability in adults with spinal metastases.

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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.