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NCT Number: NCT07809672

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location status: Recruiting

Location contact

Huanhuan Wang, MD

CONTACT

[email protected]

022-23340123

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Local failure

    Time frame: The time from randomization to local failure assessed up to 12 months

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

Secondary outcomes

  1. OS

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

    defined as the time from randomization (or study entry) to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Huanhuan Wang, MD

CONTACT

[email protected]

022-23340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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