Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases

August 30, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

Prognostic Study of Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases From Solid Tumors

This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. This treatment uses higher doses of radiation in fewer sessions (hypofractionated stereotactic body radiotherapy) delivered precisely by the Edge machine to target remaining tumor cells while protecting the spinal cord. The study aims to see if this approach improves local tumor control, improves neurological function, shortens treatment duration, and improves quality of life in these patients. The study is observational, meaning patients receive standard care, and data is collected to evaluate the outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective, observational cohort study conducted at Tianjin Medical University Cancer Institute and Hospital to evaluate the clinical outcomes of postoperative Edge (RapidArc) Stereotactic Body Radiotherapy (SBRT) in patients with spinal metastases from solid tumors. A total of 50 patients with postoperative metastatic epidural spinal cord compression (MESCC) will be enrolled. The treatment protocol prescribes a total dose of 35 Gy in 5 fractions (7 Gy per fraction) delivered using the Edge system. The Edge system features sub-millimeter precision, six-dimensional dynamic positioning, and optical surface monitoring (OSMS), which allows for a steep dose gradient, high biological effective dose (BED), and maximal spinal cord protection. The study will evaluate local control rate (LC) and neurological improvement (Frankel score) at 3 months as the primary outcome. Secondary outcomes include 1-year and 2-year LC, neurological deterioration-free survival (NDFS), overall survival (OS), and quality of life (EORTC QLQ-C30). Adverse events including acute radiation myelitis and esophagitis will be monitored. Data will be analyzed using SPSS 27.0 and R 4.3.2, with survival curves generated via the Kaplan-Meier method and Cox regression models used for prognostic factor analysis.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • 300060
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with spinal metastases from solid tumors who underwent surgery and had residual metastatic epidural spinal cord compression (MESCC) requiring postoperative radiotherapy. All participants were enrolled at Tianjin Medical University Cancer Institute and Hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Edge SBRT Group
Participants received postoperative stereotactic body radiotherapy (SBRT) using the Edge system, prescribed as 35 Gy in 5 fractions (7 Gy per fraction).
Radiation: Stereotactic Body Radiotherapy
Postoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction).
Other Names:
  • Edge System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control Rate (LC)
Time Frame: 3 months post-treatment
Proportion of patients with local tumor control, assessed by MRI showing residual tumor volume changes at 3 months post-treatment.
3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological Deterioration-Free Survival (NDFS)
Time Frame: 1 year and 2 years
Time from treatment initiation to neurological deterioration or death.
1 year and 2 years
Overall Survival (OS)
Time Frame: 1 year and 2 years
Time from treatment initiation to death from any cause.
1 year and 2 years
Quality of Life (QoL)
Time Frame: Baseline, 3 months, 1 year, and 2 years post-treatment
Change in quality of life scores assessed by the EORTC QLQ-C30 questionnaire.
Baseline, 3 months, 1 year, and 2 years post-treatment
Incidence of Adverse Events
Time Frame: Up to 2 years post-treatment
Incidence of acute radiation myelitis, esophagitis, vertebral fractures, and skin reactions, graded according to CTCAE v5.0.
Up to 2 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Xu Liming, MD, Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

August 30, 2026

First Submitted That Met QC Criteria

August 30, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20251145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to protect patient confidentiality and adhere to institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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