Stereotactic Body Radiation Therapy (SBRT)NCT07809672
Efficacy and Safety of Stereotactic Body Radiation Therapy for Spinal Metastases With Bilsky Grade 1c-3
A study testing SBRT in people with Stereotactic Body Radiation Therapy (SBRT) and Spinal Metastases, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stereotactic Body Radiation Therapy (SBRT), Spinal Metastases
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2026to 3 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- · 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.
Who cannot join
- ·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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Huanhuan Wang, MD, 022-23340123, doctor_1188@163.com
About this study
Official title: Efficacy and Safety of Stereotactic Body Radiation Therapy for Spinal Metastases With Epidural Spinal Cord Compression (Bilsky Grade 1c-3): A Prospective, Multicenter, Single-Arm Phase II Study
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).
- Being tested
- SBRT
- Keywords
- Stereotactic Body Radiation Therapy, Spinal metastases, epidural spinal cord compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| stereotactic body radiation therapy | Experimental | SBRT for patients with spinal metastases and epidural spinal cord compression (Bilsky grade 1c-3) Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure
defined as radiographic and/or clinical progression within the radiotherapy target volume.
Measured: The time from randomization to local failure assessed up to 12 months
Secondary outcomes (1)
OS
defined as the time from randomization (or study entry) to death from any cause.
Measured: the time from randomization to death from any cause assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start3 Sep 2026 (estimated)
- Primary completion3 Sep 2028 (estimated)
- Study completion3 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body Radiation Therapy (SBRT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stereotactic body radiation therapy (SBRT) in patients with spinal metastases and epidural spinal cord compression (Bilsky grade 1c-3)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809672
- Sponsor's protocol ID
- E20260985
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No