Efficacy and Safety of Stereotactic Body Radiation Therapy for Spinal Metastases With Bilsky Grade 1c-3

NCT07809672 | Recruiting

• 1 other identifier: E20260985
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Stereotactic Body Radiation Therapy (SBRT); Spinal Metastases

Keywords

Stereotactic Body Radiation Therapy; Spinal metastases; epidural spinal cord compression

Outcome Measures

Primary Outcomes (1)

• Local failure

  defined as radiographic and/or clinical progression within the radiotherapy target volume.

  The time from randomization to local failure assessed up to 12 months

Secondary Outcomes (1)

• OS

  the time from randomization to death from any cause assessed up to 12 months

Study Arms (1)

stereotactic body radiation therapy

EXPERIMENTAL

SBRT for patients with spinal metastases and epidural spinal cord compression (Bilsky grade 1c-3)

Radiation: SBRT

Interventions

SBRT RADIATION

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.

stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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.

You may not qualify if:

• ·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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Huanhuan Wang, MD

CONTACT

022-23340123; doctor_1188@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stereotactic body radiation therapy (SBRT) in patients with spinal metastases and epidural spinal cord compression (Bilsky grade 1c-3)

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): September 3, 2028
• Study Completion (Estimated): September 3, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)