Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases

NCT07801274 | Recruiting

• 1 other identifier: E20251145
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Metastases; Metastatic Epidural Spinal Cord Compression; Spinal Cord Compression

Keywords

Stereotactic Body Radiotherapy; Edge System; Postoperative Radiotherapy; Hypofractionated Radiotherapy; MESCC; Observational Study

Outcome Measures

Primary Outcomes (1)

• Local Control Rate (LC)

  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 Outcomes (4)

• Neurological Deterioration-Free Survival (NDFS)

  1 year and 2 years

• Overall Survival (OS)

  1 year and 2 years

• Quality of Life (QoL)

  Baseline, 3 months, 1 year, and 2 years post-treatment

• Incidence of Adverse Events

  Up to 2 years post-treatment

Study Arms (1)

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

Interventions

Stereotactic Body Radiotherapy RADIATION

Postoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction).

Also known as: Edge System

Edge SBRT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 to 80 years, any sex.
• Karnofsky Performance Status (KPS) \>= 60 or ECOG Performance Status \<= 2.
• Confirmed spinal metastases from solid tumors by pathology or imaging (MRI/CT).
• Postoperative imaging confirming residual epidural spinal cord compression (MESCC) requiring adjuvant radiotherapy.
• Number of lesions \<= 5, and maximum diameter of a single lesion \<= 5 cm.
• Interval between surgery and radiotherapy \<= 4 weeks.
• Signed informed consent and willingness to participate in the study.

You may not qualify if:

• Uncontrolled primary tumor (e.g., extensive metastasis or progressive disease).
• Concurrent brain metastases or other active malignancies.
• Pathological fracture or severe spinal instability requiring emergency surgical intervention.
• Prior cumulative spinal cord radiation dose exceeding the tolerance threshold (e.g., previous spinal cord Dmax \>= 45 Gy).
• Contraindications to radiotherapy (e.g., severe cardiopulmonary dysfunction, coagulation disorders).
• Severe postoperative complications (e.g., infection, poor wound healing) requiring delayed radiotherapy.
• Incomplete or unreliable medical records from external hospitals.
• Pregnant or lactating women.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

300060

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (1)

• Guckenberger M, Andratschke N, Belka C, Bellut D, Cuccia F, Dahele M, Guninski RS, Josipovic M, Mancosu P, Minniti G, Niyazi M, Ricardi U, Munck Af Rosenschold P, Sahgal A, Tsang Y, Verbakel W, Alongi F. ESTRO clinical practice guideline: Stereotactic body radiotherapy for spine metastases. Radiother Oncol. 2024 Jan;190:109966. doi: 10.1016/j.radonc.2023.109966. Epub 2023 Nov 2.

  PMID: 37925107 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Compression

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xu Liming, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Liming, MD

CONTACT

86-22-23340123; xuliming@tjmuch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 3, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)