Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Stereotactic Body Radiotherapy
RadiationPostoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction).
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Edge SBRT Group1 intervention
Trial outcomes
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.
Time frame
3 months post-treatmentSecondary outcomes
1
Neurological Deterioration-Free Survival (NDFS)
Time from treatment initiation to neurological deterioration or death.
Time frame
1 year and 2 years2
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Time frame
1 year and 2 years3
Quality of Life (QoL)
Change in quality of life scores assessed by the EORTC QLQ-C30 questionnaire.
Time frame
Baseline, 3 months, 1 year, and 2 years post-treatment4
Incidence of Adverse Events
Incidence of acute radiation myelitis, esophagitis, vertebral fractures, and skin reactions, graded according to CTCAE v5.0.
Time frame
Up to 2 years post-treatmentSponsors and contacts
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Source ClinicalTrials.gov